PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Drills, Burrs, Trephines & Accessories (Compound, 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 §882.4305 (Neurology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#431 of 1000 · 2,726 reports · 1993–2026

  • BOOK 2,726 reports
  • RANK #431 of 1000
  • DEATH 2 death-typed
  • INJ 1,347 injury-typed
  • MALF 1,328 malfunction
  • SPAN 1993–2026
  • PEAK 2020: 324
  • PHOTO System

Nearest event-volume peer: System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment (5 report gap)

Drills, Burrs, Trephines & Accessories (Compound, Powered) sits #431 of 1000 among tracked device types with 2,726 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 →

Injury-coded reports run above the device-type norm

Drills, Burrs, Trephines & Accessories carries 49.4% INJURY-coded reports, 19.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 49.4% corpus 30.3% · above corpus mean (+19.1 pp)
  • MALF 48.7% corpus 64.8% · below corpus mean (-16.1 pp)

Lead product-problem code Failure to Auto Stop is 26% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 56% of manufacturer-tagged reports · Top event location is 51% 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 (Compound, Powered) carries 2,726 MAUDE reports, ranked #431 of 1000.

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

Event Types

Injury 1,347 (49.4%)
Malfunction 1,328 (48.7%)
Other 37 (1.4%)
12 (0.4%)
Death 2 (0.1%)

Patient Outcomes

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

1,525 (55.7%)
Other 599 (21.9%)
Required Intervention 569 (20.8%)
R 14 (0.5%)
Hospitalization 10 (0.4%)
O 5 (0.2%)
Life Threatening 5 (0.2%)
Death 4 (0.1%)
Disability 3 (0.1%)
H 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Failure to Auto Stop 648
Device Remains Activated 479
Fail-Safe Did Not Operate 207
Activation, Positioning or Separation Problem 166
Break 124
Other (for use when an appropriate device code cannot be identified) 100
Plunge 93
Dull, Blunt 84
Mechanical Problem 80
Sticking 65
Material Separation 58
Device Operates Differently Than Expected 54
Device Issue 48
Appropriate Device Problem Term/Code Not Available 46
Adverse Event Without Identified Device or Use Problem 41
Difficult to Remove 40
Insufficient Device Problem Information 33
Use of Device Problem 33
Fracture 27
Detachment of Device or Device Component 23

Yearly Trend

93
1993: 3
94
1994: 1
95
1995: 12
96
1996: 38
97
1997: 34
98
1998: 15
99
1999: 21
00
2000: 17
01
2001: 31
02
2002: 51
03
2003: 57
04
2004: 78
05
2005: 47
06
2006: 16
07
2007: 25
08
2008: 41
09
2009: 34
10
2010: 73
11
2011: 39
12
2012: 79
13
2013: 103
14
2014: 95
15
2015: 59
16
2016: 76
17
2017: 106
18
2018: 136
19
2019: 208
20
2020: 324
21
2021: 309
22
2022: 148
23
2023: 108
24
2024: 183
25
2025: 115
26
2026: 44

Reports in 2025 (115) held close to the prior two-year average of 146.

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

Top Manufacturers

STRYKER INSTRUMENTS-KALAMAZOO 216
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 120
THE ANSPACH EFFORT, INC. 50

Event Locations

1,377 (50.5%)
I 1,075 (39.4%)
HOSPITAL 206 (7.6%)
INVALID DATA 41 (1.5%)
NO INFORMATION 18 (0.7%)
OTHER 4 (0.1%)
NURSING HOME 3 (0.1%)
HOME 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare STRYKER INSTRUMENTS-KALAMAZOO vs STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP →

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 (2,726 here).

System 2,731 Vehicle, Motorized 3-Wheeled 2,715 Bur, Ear, Nose And Throat 2,714 Real Time Nucleic Acid Amplification System 2,746

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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.