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2026 data FDA MAUDE openFDA FDA Class II

Drill, Bone, 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 §872.4120 (Dental panel).

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FDA MAUDE casebook

openFDA event book Drill, Bone, Powered LIGHT-BOOK · MAUDE

#652 of 1000 · 1,051 reports · 1992–2026

  • BOOK 1,051 reports
  • RANK #652 of 1000
  • DEATH 0 death-typed
  • INJ 239 injury-typed
  • MALF 789 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 84
  • PHOTO System

Nearest event-volume peer: System, Tomography, Computed, Emission (0 report gap)

Drill, Bone, Powered sits #652 of 1000 among tracked device types with 1,051 MAUDE reports spanning 1992–2026. 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

Drill, Bone, Powered carries 75.1% MALFUNCTION-coded reports, 10.2pp 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 22.7% corpus 30.3% · below corpus mean (-7.6 pp)
  • MALF 75.1% corpus 64.8% · above corpus mean (+10.2 pp)

Lead product-problem code Break is 43% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 49% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Drill, Bone, Powered in the event-volume neighbourhood

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

reports

What this shows Drill, Bone, Powered carries 1,051 MAUDE reports, ranked #652 of 1000.

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

Event Types

Malfunction 789 (75.1%)
Injury 239 (22.7%)
Other 20 (1.9%)
3 (0.3%)

Patient Outcomes

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

782 (73.9%)
Required Intervention 203 (19.2%)
Other 53 (5.0%)
R 13 (1.2%)
Hospitalization 5 (0.5%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 446
Overheating of Device 111
Failure to Cut 80
Device-Device Incompatibility 74
Entrapment of Device 52
Heat 41
Device Operates Differently Than Expected 34
Replace 28
Unknown (for use when the device problem is not known) 27
Self-Activation or Keying 22
Material Twisted/Bent 19
Detachment Of Device Component 17
Material Fragmentation 17
Device Markings/Labelling Problem 16
Temperature Problem 12
Fracture 11
Use of Device Problem 11
Material Deformation 10
Bent 9
Detachment of Device or Device Component 9

Yearly Trend

92
1992: 2
95
1995: 3
96
1996: 2
97
1997: 14
98
1998: 5
99
1999: 9
00
2000: 16
01
2001: 9
02
2002: 7
03
2003: 13
04
2004: 8
05
2005: 16
06
2006: 10
07
2007: 53
08
2008: 45
09
2009: 22
10
2010: 15
11
2011: 42
12
2012: 25
13
2013: 57
14
2014: 50
15
2015: 39
16
2016: 43
17
2017: 38
18
2018: 73
19
2019: 50
20
2020: 55
21
2021: 84
22
2022: 63
23
2023: 63
24
2024: 58
25
2025: 40
26
2026: 22

Reports in 2025 (40) held close to the prior two-year average of 61.

Related Entities for Drill, Bone, Powered

Top Manufacturers

SYNTHES GMBH 339
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 86
OBERDORF SYNTHES PRODUKTIONS GMBH 81
STRYKER INSTRUMENTS KALAMAZOO 69
SYNTHES MONUMENT 50
SYNTHES USA 34
IMPLANT DIRECT SYBRON MANUFACTURING LLC 33

Event Locations

631 (60.0%)
I 327 (31.1%)
HOSPITAL 46 (4.4%)
OUTPATIENT TREATMENT FACILITY 27 (2.6%)
OTHER 14 (1.3%)
AMBULATORY SURGICAL FACILITY 3 (0.3%)
NO INFORMATION 2 (0.2%)
UNKNOWN 1 (0.1%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable report-volume footprint

Drill, Bone, Powered carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,051 here).

System, Tomography, Computed, Emission 1,051 Prosthesis, Rib Replacement 1,052 Holder, Needle, Gastroenterologic 1,038 Cannula, Surgical, General & Plastic Surgery 1,037

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Drill, Bone, Powered 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 Drill, Bone, Powered; 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.