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2026 data FDA MAUDE openFDA FDA Class I

Burr, Orthopedic

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 §888.4540 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Burr, Orthopedic LIGHT-BOOK · MAUDE

#955 of 1000 · 414 reports · 1992–2026

  • BOOK 414 reports
  • RANK #955 of 1000
  • DEATH 0 death-typed
  • INJ 63 injury-typed
  • MALF 313 malfunction
  • SPAN 1992–2026
  • PEAK 2008: 56
  • PHOTO System

Nearest event-volume peer: System, Applicator, Radionuclide, Remote-Controlled (1 report gap)

Burr, Orthopedic sits #955 of 1000 among tracked device types with 414 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 →

Injury-coded reports sit below the device-type norm

Burr, Orthopedic carries 15.2% INJURY-coded reports, 15.1pp below 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 15.2% corpus 30.3% · below corpus mean (-15.1 pp)
  • MALF 75.6% corpus 64.8% · above corpus mean (+10.8 pp)

Lead product-problem code Break is 24% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 51% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Burr, Orthopedic in the event-volume neighbourhood

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

reports

What this shows Burr, Orthopedic carries 414 MAUDE reports, ranked #955 of 1000.

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

Event Types

Malfunction 313 (75.6%)
Injury 63 (15.2%)
Other 29 (7.0%)
9 (2.2%)

Patient Outcomes

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

286 (68.3%)
Other 79 (18.9%)
Required Intervention 45 (10.7%)
R 4 (1.0%)
Disability 2 (0.5%)
Hospitalization 2 (0.5%)
S 1 (0.2%)

Top Product Problems

Break 111
Device, or device fragments remain in patient 44
Tip breakage 44
Metal Shedding Debris 43
Unknown (for use when the device problem is not known) 36
Overheating of Device 29
Replace 25
Detachment Of Device Component 23
Device, removal of (non-implant) 18
Flaked 14
Heat 14
Difficult to Remove 12
Component(s), broken 11
Tear, Rip or Hole in Device Packaging 9
Fracture 7
Material Fragmentation 7
Use of Device Problem 7
Bent 6
Material Separation 6
Out-Of-Box Failure 6

Yearly Trend

92
1992: 4
93
1993: 2
94
1994: 5
95
1995: 9
96
1996: 11
97
1997: 14
98
1998: 17
99
1999: 14
00
2000: 15
01
2001: 10
02
2002: 3
03
2003: 8
04
2004: 11
05
2005: 32
06
2006: 33
07
2007: 26
08
2008: 56
09
2009: 35
10
2010: 30
11
2011: 9
12
2012: 16
13
2013: 6
14
2014: 7
15
2015: 17
16
2016: 9
17
2017: 1
18
2018: 2
19
2019: 2
20
2020: 2
21
2021: 2
22
2022: 3
23
2023: 2
26
2026: 1

Reports in 2023 (2) held close to the prior two-year average of 3.

Related Entities for Burr, Orthopedic

Top Manufacturers

STRYKER INSTRUMENTS-KALAMAZOO 20
DEPUY MITEK 19

Event Locations

226 (54.6%)
HOSPITAL 135 (32.6%)
I 28 (6.8%)
AMBULATORY SURGICAL FACILITY 8 (1.9%)
OTHER 5 (1.2%)
UNKNOWN 5 (1.2%)
INVALID DATA 3 (0.7%)
NO INFORMATION 2 (0.5%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.2%)

Compare STRYKER INSTRUMENTS-KALAMAZOO vs DEPUY MITEK →

Nationwide devices with a comparable report-volume footprint

Burr, Orthopedic 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 (414 here).

System 413 Pliers, Surgical 412 Stimulator, Carotid Sinus Nerve 416 Manometer, Spinal-Fluid 411

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 Burr, Orthopedic 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 Burr, Orthopedic; 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.