PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Bur, Dental

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 §872.3240 (Dental panel).

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FDA MAUDE casebook

openFDA event book Bur, Dental LIGHT-BOOK · MAUDE

#875 of 1000 · 523 reports · 1993–2026

  • BOOK 523 reports
  • RANK #875 of 1000
  • DEATH 0 death-typed
  • INJ 148 injury-typed
  • MALF 356 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 56
  • PHOTO Display

Nearest event-volume peer: Display, Cathode-Ray Tube, Medical (2 report gap)

Bur, Dental sits #875 of 1000 among tracked device types with 523 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

Bur, Dental carries 68.1% MALFUNCTION-coded reports, 3.2pp 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 28.3% corpus 30.3% · below corpus mean (-2.0 pp)
  • MALF 68.1% corpus 64.8% · above corpus mean (+3.2 pp)

Lead product-problem code Break is 39% of coded problems · Lead manufacturer STRYKER INSTRUMENTS KALAMAZOO accounts for 44% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Bur, Dental in the event-volume neighbourhood

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

reports

What this shows Bur, Dental carries 523 MAUDE reports, ranked #875 of 1000.

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

Event Types

Malfunction 356 (68.1%)
Injury 148 (28.3%)
15 (2.9%)
Other 4 (0.8%)

Patient Outcomes

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

352 (65.7%)
Required Intervention 86 (16.0%)
Other 63 (11.8%)
Disability 10 (1.9%)
R 9 (1.7%)
Hospitalization 8 (1.5%)
O 4 (0.7%)
Death 3 (0.6%)
S 1 (0.2%)

Top Product Problems

Break 169
Material Separation 43
Fracture 27
Detachment of Device or Device Component 25
Melted 22
Detachment Of Device Component 21
Overheating of Device 20
Insufficient Device Problem Information 13
Tip breakage 13
Bent 12
Adverse Event Without Identified Device or Use Problem 10
Device, or device fragments remain in patient 9
Unknown (for use when the device problem is not known) 8
Device, removal of (non-implant) 7
Crack 6
Material Fragmentation 6
Component(s), broken 5
Device Dislodged or Dislocated 4
Entrapment of Device 4
Heat 4

Yearly Trend

93
1993: 2
94
1994: 4
95
1995: 5
96
1996: 15
97
1997: 42
98
1998: 34
99
1999: 10
00
2000: 3
01
2001: 4
02
2002: 4
03
2003: 2
04
2004: 1
05
2005: 6
06
2006: 29
07
2007: 5
08
2008: 32
09
2009: 53
10
2010: 7
11
2011: 8
12
2012: 3
13
2013: 12
14
2014: 6
15
2015: 7
16
2016: 18
17
2017: 19
18
2018: 15
19
2019: 17
20
2020: 7
21
2021: 21
22
2022: 19
23
2023: 9
24
2024: 25
25
2025: 56
26
2026: 23

Reports rose to 56 in 2025, up from an average of 17 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Bur, Dental

Top Manufacturers

STRYKER INSTRUMENTS KALAMAZOO 44
STRYKER INSTRUMENTS-KALAMAZOO 41
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 15

Event Locations

280 (53.5%)
I 85 (16.3%)
HOSPITAL 63 (12.0%)
OUTPATIENT TREATMENT FACILITY 40 (7.6%)
OTHER 35 (6.7%)
NO INFORMATION 8 (1.5%)
INVALID DATA 5 (1.0%)
UNKNOWN 4 (0.8%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)

Compare STRYKER INSTRUMENTS KALAMAZOO vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable report-volume footprint

Bur, Dental 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 (523 here).

Display, Cathode-Ray Tube, Medical 525 Unit, X-Ray, Extraoral With Timer 521 Drug-Coated Peripheral Transluminal Angiopl… 526 Apparatus, Traction, Non-Powered 519

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 Bur, Dental 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 Bur, Dental; 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.