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Joint, Temporomandibular, Implant

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Joint, Temporomandibular, Implant

The FDA MAUDE database aggregates 3,015 adverse-event reports for Joint, Temporomandibular, Implant spanning the period from 1992 through 2026. Of these, 7 are classified as death reports, 2,694 as injury reports, and 184 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 15 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 1,164 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 255 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 12 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

3,015
Total Reports
7
Death Reports
2,694
Injury Reports
184
Malfunctions

Event Types

Injury 2,694 (89.4%)
Malfunction 184 (6.1%)
Other 69 (2.3%)
61 (2.0%)
Death 7 (0.2%)

Patient Outcomes

Required Intervention 1,194 (27.6%)
Hospitalization 1,041 (24.1%)
R 809 (18.7%)
Other 506 (11.7%)
S 180 (4.2%)
161 (3.7%)
O 152 (3.5%)
H 121 (2.8%)
Disability 72 (1.7%)
L 49 (1.1%)
Life Threatening 24 (0.6%)
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 1,164
Insufficient Information 178
Device Dislodged or Dislocated 133
Malposition of Device 105
Inadequacy of Device Shape and/or Size 70
Fracture 69
Patient Device Interaction Problem 69
Nonstandard Device 68
Patient-Device Incompatibility 63
Migration or Expulsion of Device 49
Noise, Audible 47
Device Appears to Trigger Rejection 42
Migration 39
Loosening of Implant Not Related to Bone-Ingrowth 38
Loss of Osseointegration 19
Fitting Problem 18
Loose or Intermittent Connection 18
Positioning Problem 16
Appropriate Term/Code Not Available 13
No Apparent Adverse Event 10

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: 55

Related Entities for Joint, Temporomandibular, Implant

Event Locations

1,633 (54.2%)
I 1,042 (34.6%)
HOSPITAL 98 (3.3%)
UNKNOWN 95 (3.2%)
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%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.