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2026 data FDA MAUDE openFDA FDA Class I

Drill, Dental, Intraoral

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.4130 (Dental panel).

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FDA MAUDE casebook

openFDA event book Drill, Dental, Intraoral LIGHT-BOOK · MAUDE

#830 of 1000 · 599 reports · 1992–2026

  • BOOK 599 reports
  • RANK #830 of 1000
  • DEATH 0 death-typed
  • INJ 97 injury-typed
  • MALF 476 malfunction
  • SPAN 1992–2026
  • PEAK 2005: 139
  • PHOTO Pacemaker

Nearest event-volume peer: Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) (0 report gap)

Drill, Dental, Intraoral sits #830 of 1000 among tracked device types with 599 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, Dental, Intraoral carries 79.5% MALFUNCTION-coded reports, 14.6pp 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 16.2% corpus 30.3% · below corpus mean (-14.1 pp)
  • MALF 79.5% corpus 64.8% · above corpus mean (+14.6 pp)

Lead product-problem code Material Separation is 43% of coded problems · Lead manufacturer STRYKER INSTRUMENTS KALAMAZOO accounts for 100% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Drill, Dental, Intraoral in the event-volume neighbourhood

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

reports

What this shows Drill, Dental, Intraoral carries 599 MAUDE reports, ranked #830 of 1000.

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

Event Types

Malfunction 476 (79.5%)
Injury 97 (16.2%)
Other 17 (2.8%)
9 (1.5%)

Patient Outcomes

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

406 (67.0%)
Other 101 (16.7%)
Required Intervention 85 (14.0%)
R 4 (0.7%)
Disability 4 (0.7%)
O 2 (0.3%)
Not Applicable 2 (0.3%)
Hospitalization 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Material Separation 324
Device, or device fragments remain in patient 143
Break 92
Overheating of Device 67
Fracture 18
Unknown (for use when the device problem is not known) 17
Detachment Of Device Component 16
Heat 13
Replace 11
Difficult to Remove 8
Melted 8
Use of Device Problem 8
Device, removal of (non-implant) 7
Bent 5
Improper or Incorrect Procedure or Method 5
Component Falling 4
Insufficient Device Problem Information 4
Other (for use when an appropriate device code cannot be identified) 4
Adverse Event Without Identified Device or Use Problem 3
Entrapment of Device 3

Yearly Trend

92
1992: 3
94
1994: 3
95
1995: 2
96
1996: 6
97
1997: 17
98
1998: 3
99
1999: 2
00
2000: 1
01
2001: 1
02
2002: 1
03
2003: 22
04
2004: 85
05
2005: 139
06
2006: 88
07
2007: 13
08
2008: 14
09
2009: 57
10
2010: 13
11
2011: 6
12
2012: 11
13
2013: 6
14
2014: 17
15
2015: 9
16
2016: 14
17
2017: 13
18
2018: 14
19
2019: 14
20
2020: 9
21
2021: 8
22
2022: 1
23
2023: 1
24
2024: 2
25
2025: 3
26
2026: 1

Reports rose to 3 in 2025, up from an average of 2 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Drill, Dental, Intraoral

Top Manufacturers

STRYKER INSTRUMENTS KALAMAZOO 55

Event Locations

474 (79.1%)
I 56 (9.3%)
HOSPITAL 23 (3.8%)
OTHER 19 (3.2%)
NO INFORMATION 10 (1.7%)
OUTPATIENT TREATMENT FACILITY 7 (1.2%)
INVALID DATA 4 (0.7%)
UNKNOWN 3 (0.5%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
NOT APPLICABLE 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Drill, Dental, Intraoral 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 (599 here).

Pacemaker, Cardiac, External Transcutaneous 599 Neurosurgical Paddie 600 Device, Anastomotic, Microvascular 601 Suture, Nonabsorbable 601

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, Dental, Intraoral 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, Dental, Intraoral; 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.