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2026 data FDA MAUDE openFDA FDA Class II

Drills, Burrs, Trephines & Accessories (Simple, Powered)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §882.4310 (Neurology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Drills, Burrs, Trephines & Accessories MID-BOOK · MAUDE

#136 of 1000 · 21,585 reports · 1993–2026

  • BOOK 21,585 reports
  • RANK #136 of 1000
  • DEATH 3 death-typed
  • INJ 692 injury-typed
  • MALF 20,850 malfunction
  • SPAN 1993–2026
  • PEAK 2026: 5,289
  • PHOTO Port & Catheter

Nearest event-volume peer: Port & Catheter, Implanted, Subcutaneous, Intravascular (358 report gap)

Drills, Burrs, Trephines & Accessories (Simple, Powered) sits #136 of 1000 among tracked device types with 21,585 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Drills, Burrs, Trephines & Accessories carries 96.6% MALFUNCTION-coded reports, 31.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.2% corpus 30.3% · below corpus mean (-27.1 pp)
  • MALF 96.6% corpus 64.8% · above corpus mean (+31.8 pp)

Lead product-problem code Overheating of Device is 29% of coded problems · Lead manufacturer MDT POWERED SURGICAL SOLUTIONS accounts for 34% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Drills, Burrs, Trephines & Accessories in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Drills, Burrs, Trephines & Accessories (Simple, Powered) carries 21,585 MAUDE reports, ranked #136 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 20,850 (96.6%)
Injury 692 (3.2%)
20 (0.1%)
Other 20 (0.1%)
Death 3 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

19,631 (95.8%)
Other 424 (2.1%)
Required Intervention 321 (1.6%)
R 38 (0.2%)
Hospitalization 36 (0.2%)
O 12 (0.1%)
Death 11 (0.1%)
Disability 11 (0.1%)
Congenital Anomaly 3 (0.0%)
S 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Overheating of Device 5,994
Fracture 2,402
Break 2,053
No Apparent Adverse Event 1,735
Flaked 1,406
Detachment of Device or Device Component 1,385
Naturally Worn 793
Vibration 756
Difficult to Insert 575
Self-Activation or Keying 521
Device Operates Differently Than Expected 388
Temperature Problem 374
Noise, Audible 340
Bent 308
Device Displays Incorrect Message 300
Excessive Heating 275
Difficult to Remove 273
Fluid/Blood Leak 247
Detachment Of Device Component 227
Material Fragmentation 226

Yearly Trend

93
1993: 1
94
1994: 1
97
1997: 5
00
2000: 36
01
2001: 252
02
2002: 31
03
2003: 18
04
2004: 24
05
2005: 34
06
2006: 12
07
2007: 14
08
2008: 14
09
2009: 242
10
2010: 492
11
2011: 1,013
12
2012: 1,146
13
2013: 1,583
14
2014: 559
15
2015: 483
16
2016: 849
17
2017: 848
18
2018: 787
19
2019: 836
20
2020: 1,025
21
2021: 1,047
22
2022: 900
23
2023: 948
24
2024: 1,153
25
2025: 1,943
26
2026: 5,289

Reports rose to 1,943 in 2025, up from an average of 1,051 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Drills, Burrs, Trephines & Accessories (Simple, Powered)

Top Manufacturers

MDT POWERED SURGICAL SOLUTIONS 6,411
STRYKER INSTRUMENTS-KALAMAZOO 2,891
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2,628
STRYKER INSTRUMENTS KALAMAZOO 2,025
DEPUY SYNTHES POWER TOOLS 2,003
MEDTRONIC XOMED INC. 1,474
DEPUY SYNTHES PRODUCTS LLC 952
MDT Powered Surgical Solutions 473

Event Locations

15,675 (72.6%)
I 5,485 (25.4%)
HOSPITAL 387 (1.8%)
NO INFORMATION 27 (0.1%)
OTHER 5 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare MDT POWERED SURGICAL SOLUTIONS vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drills, Burrs, Trephines & Accessories: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (21,585 here).

Port & Catheter 21,943 Lens, Intraocular, Phakic 21,997 General Surgery Tray 20,596 Implant, Dermal, For Aesthetic Use 22,615

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Drills, Burrs, Trephines & Accessories are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Drills, Burrs, Trephines & Accessories; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.