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2026 data FDA MAUDE openFDA FDA Class III

Joint, Temporomandibular, Implant

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 III (highest risk, premarket approval required), regulated under 21 CFR §872.3940 (Dental panel).

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FDA MAUDE casebook

openFDA event book Joint, Temporomandibular, Implant LIGHT-BOOK · MAUDE

#400 of 1000 · 3,096 reports · 1992–2026

  • BOOK 3,096 reports
  • RANK #400 of 1000
  • DEATH 7 death-typed
  • INJ 2,767 injury-typed
  • MALF 192 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 255
  • PHOTO Ventilator

Nearest event-volume peer: Ventilator, High Frequency (1 report gap)

Joint, Temporomandibular, Implant sits #400 of 1000 among tracked device types with 3,096 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 run above the device-type norm

Joint, Temporomandibular, Implant carries 89.4% INJURY-coded reports, 59.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 89.4% corpus 30.3% · above corpus mean (+59.1 pp)
  • MALF 6.2% corpus 64.8% · below corpus mean (-58.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 40% of coded problems · Lead manufacturer BIOMET MICROFIXATION accounts for 99% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Joint, Temporomandibular, Implant in the event-volume neighbourhood

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

reports

What this shows Joint, Temporomandibular, Implant carries 3,096 MAUDE reports, ranked #400 of 1000.

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

Event Types

Injury 2,767 (89.4%)
Malfunction 192 (6.2%)
Other 69 (2.2%)
61 (2.0%)
Death 7 (0.2%)

Patient Outcomes

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

Required Intervention 1,234 (27.9%)
Hospitalization 1,051 (23.8%)
R 820 (18.6%)
Other 529 (12.0%)
S 181 (4.1%)
166 (3.8%)
O 154 (3.5%)
H 124 (2.8%)
Disability 72 (1.6%)
L 49 (1.1%)
Life Threatening 24 (0.5%)
Death 7 (0.2%)
Not Applicable 3 (0.1%)
Congenital Anomaly 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,284
Insufficient Device Problem Information 430
Explanted 195
Device Dislodged or Dislocated 178
Malposition of Device 140
Fracture 103
Inadequacy of Device Shape and/or Size 102
Patient-Device Incompatibility 98
Nonstandard Device 85
Migration or Expulsion of Device 77
Patient Device Interaction Problem 71
Device Appears to Trigger Rejection 59
Noise, Audible 53
Replace 52
Device remains implanted 48
Break 47
Device Operates Differently Than Expected 44
Appropriate Device Problem Term/Code Not Available 43
Reaction 43
Migration 41

Yearly Trend

92
1992: 4
93
1993: 8
94
1994: 44
95
1995: 33
96
1996: 26
97
1997: 12
98
1998: 25
99
1999: 33
00
2000: 34
01
2001: 18
02
2002: 20
03
2003: 16
04
2004: 29
05
2005: 46
06
2006: 34
07
2007: 22
08
2008: 22
09
2009: 32
10
2010: 49
11
2011: 69
12
2012: 73
13
2013: 104
14
2014: 96
15
2015: 146
16
2016: 131
17
2017: 95
18
2018: 210
19
2019: 204
20
2020: 255
21
2021: 207
22
2022: 193
23
2023: 236
24
2024: 207
25
2025: 227
26
2026: 136

Reports in 2025 (227) held close to the prior two-year average of 222.

Related Entities for Joint, Temporomandibular, Implant

Top Manufacturers

BIOMET MICROFIXATION 1,771
UNKNOWN 20

Event Locations

1,713 (55.3%)
I 1,042 (33.7%)
HOSPITAL 99 (3.2%)
UNKNOWN 95 (3.1%)
NO INFORMATION 48 (1.6%)
HOME 39 (1.3%)
NOT APPLICABLE 24 (0.8%)
INVALID DATA 18 (0.6%)
OTHER 11 (0.4%)
AMBULATORY SURGICAL FACILITY 5 (0.2%)
CLINIC - WALK IN, OTHER 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare BIOMET MICROFIXATION vs UNKNOWN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Joint, Temporomandibular, Implant: 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 (3,096 here).

Ventilator, High Frequency 3,097 Prosthesis, Esophageal 3,094 Test, Hepatitis B 3,089 Monitor, Cardiac 3,110

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Mesh, Surgical, Absorbable, Abdominal Hernia 7

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

Disclaimer: MAUDE figures for Joint, Temporomandibular, Implant 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 Joint, Temporomandibular, Implant; 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.