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2026 data FDA MAUDE openFDA FDA Class II

Abutment, Implant, Dental, Endosseous

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 II (moderate risk, special controls required), regulated under 21 CFR §872.3630 (Dental panel).

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FDA MAUDE casebook

openFDA event book Abutment, Implant, Dental, Endosseous LIGHT-BOOK · MAUDE

#240 of 1000 · 8,409 reports · 2003–2026

  • BOOK 8,409 reports
  • RANK #240 of 1000
  • DEATH 1 death-typed
  • INJ 2,685 injury-typed
  • MALF 5,714 malfunction
  • SPAN 2003–2026
  • PEAK 2026: 1,481
  • PHOTO Acid

Nearest event-volume peer: Acid, Hyaluronic, Intraarticular (1 report gap)

Abutment, Implant, Dental, Endosseous sits #240 of 1000 among tracked device types with 8,409 MAUDE reports spanning 2003–2026. 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

Abutment, Implant, Dental, Endosseous carries 68.0% MALFUNCTION-coded reports, 3.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 31.9% corpus 30.3% · above corpus mean (+1.6 pp)
  • MALF 68.0% corpus 64.8% · above corpus mean (+3.1 pp)

Lead product-problem code Fracture is 66% of coded problems · Lead manufacturer BIOMET 3I accounts for 64% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Abutment, Implant, Dental, Endosseous in the event-volume neighbourhood

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

reports

What this shows Abutment, Implant, Dental, Endosseous carries 8,409 MAUDE reports, ranked #240 of 1000.

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

Event Types

Malfunction 5,714 (68.0%)
Injury 2,685 (31.9%)
Other 7 (0.1%)
2 (0.0%)
Death 1 (0.0%)

Patient Outcomes

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

5,395 (63.2%)
Required Intervention 2,476 (29.0%)
Other 437 (5.1%)
R 153 (1.8%)
Disability 21 (0.2%)
S 15 (0.2%)
O 12 (0.1%)
Hospitalization 11 (0.1%)
C 4 (0.0%)
H 2 (0.0%)
L 2 (0.0%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Fracture 5,560
Unintended Movement 755
Positioning Failure 427
Mechanical Problem 303
Failure to Osseointegrate 227
Break 178
Separation Failure 168
Migration or Expulsion of Device 136
Use of Device Problem 78
Loose or Intermittent Connection 72
Failure to Advance 69
Insufficient Device Problem Information 62
Positioning Problem 56
Difficult to Remove 52
Loss of Osseointegration 48
Separation Problem 46
Adverse Event Without Identified Device or Use Problem 41
Connection Problem 40
No Apparent Adverse Event 38
Patient Device Interaction Problem 37

Yearly Trend

03
2003: 1
05
2005: 2
07
2007: 1
08
2008: 8
09
2009: 30
10
2010: 61
11
2011: 56
12
2012: 5
13
2013: 143
14
2014: 146
15
2015: 858
16
2016: 314
17
2017: 577
18
2018: 591
19
2019: 530
20
2020: 458
21
2021: 546
22
2022: 497
23
2023: 618
24
2024: 636
25
2025: 850
26
2026: 1,481

Reports in 2025 (850) held close to the prior two-year average of 627.

Related Entities for Abutment, Implant, Dental, Endosseous

Top Manufacturers

BIOMET 3I 4,657
DENTSPLY IMPLANTS MANUFACTURING GMBH 752
ZIMMER DENTAL 743
BIOHORIZONS IMPLANT SYSTEMS 352
ZIMVIE US CORP LLC 338
IMPLANT DIRECT SYBRON MANUFACTURING LLC 163
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) 142
MIS IMPLANTS TECHNOLOGIES LTD. 119

Event Locations

5,327 (63.3%)
I 3,016 (35.9%)
NO INFORMATION 29 (0.3%)
OTHER 20 (0.2%)
AMBULATORY SURGICAL FACILITY 10 (0.1%)
OUTPATIENT TREATMENT FACILITY 5 (0.1%)
HOME 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare BIOMET 3I vs DENTSPLY IMPLANTS MANUFACTURING GMBH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Abutment, Implant, Dental, Endosseous: 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 (8,409 here).

Acid, Hyaluronic, Intraarticular 8,410 Dialyzer, Capillary, Hollow Fiber 8,424 Hysteroscope 8,394 Catheter, Peripheral, Atherectomy 8,451

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1 Aligner, Sequential 1

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

Disclaimer: MAUDE figures for Abutment, Implant, Dental, Endosseous 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 Abutment, Implant, Dental, Endosseous; 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.