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2026 data FDA MAUDE openFDA FDA Class I

Accessories, 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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.3980 (Dental panel).

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FDA MAUDE casebook

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

#322 of 1000 · 4,902 reports · 2007–2026

  • BOOK 4,902 reports
  • RANK #322 of 1000
  • DEATH 0 death-typed
  • INJ 940 injury-typed
  • MALF 3,960 malfunction
  • SPAN 2007–2026
  • PEAK 2026: 2,396
  • PHOTO Biopsy Needle

Nearest event-volume peer: Biopsy Needle (10 report gap)

Accessories, Implant, Dental, Endosseous sits #322 of 1000 among tracked device types with 4,902 MAUDE reports spanning 2007–2026. 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

Accessories, Implant, Dental, Endosseous carries 80.8% MALFUNCTION-coded reports, 16.0pp 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 19.2% corpus 30.3% · below corpus mean (-11.1 pp)
  • MALF 80.8% corpus 64.8% · above corpus mean (+16.0 pp)

Lead product-problem code Fracture is 56% of coded problems · Lead manufacturer DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) accounts for 47% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

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

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

reports

What this shows Accessories, Implant, Dental, Endosseous carries 4,902 MAUDE reports, ranked #322 of 1000.

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

Event Types

Malfunction 3,960 (80.8%)
Injury 940 (19.2%)
Other 2 (0.0%)

Patient Outcomes

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

3,598 (73.0%)
Required Intervention 1,168 (23.7%)
Other 107 (2.2%)
R 30 (0.6%)
O 10 (0.2%)
Disability 8 (0.2%)
Hospitalization 3 (0.1%)
L 2 (0.0%)
H 1 (0.0%)

Top Product Problems

Fracture 2,654
Mechanical Problem 574
Separation Failure 434
Detachment of Device or Device Component 296
Adverse Event Without Identified Device or Use Problem 236
Break 77
Use of Device Problem 61
Material Deformation 53
Positioning Failure 49
Insufficient Device Problem Information 41
Malposition of Device 41
Mechanical Jam 41
Device Damaged by Another Device 37
Appropriate Device Problem Term/Code Not Available 21
Defective Device 21
Loose or Intermittent Connection 20
Failure to Osseointegrate 19
Sticking 19
Osseointegration Problem 17
Difficult to Remove 16

Yearly Trend

07
2007: 1
08
2008: 2
10
2010: 12
11
2011: 25
12
2012: 10
13
2013: 2
14
2014: 41
15
2015: 103
16
2016: 96
17
2017: 240
18
2018: 278
19
2019: 262
20
2020: 183
21
2021: 237
22
2022: 188
23
2023: 212
24
2024: 224
25
2025: 390
26
2026: 2,396

Reports rose to 390 in 2025, up from an average of 218 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Accessories, Implant, Dental, Endosseous

Top Manufacturers

DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) 1,897
BIOMET 3I 866
DENTSPLY IMPLANTS MANUFACTURING GMBH 515
ZIMMER DENTAL 382
IMPLANT DIRECT SYBRON MANUFACTURING LLC 205
ZIMVIE US CORP LLC 114
PRISMATIK DENTALCRAFT, INC. 77

Event Locations

3,662 (74.7%)
I 1,203 (24.5%)
OTHER 18 (0.4%)
NO INFORMATION 16 (0.3%)
HOSPITAL 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) vs BIOMET 3I →

Nationwide devices with a comparable report-volume footprint

Accessories, Implant, Dental, Endosseous 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 (4,902 here).

Biopsy Needle 4,892 Lavage, Jet 4,888 Lenses, Soft Contact, Daily Wear 4,868 Catheter, Flow Directed 4,863

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, Photographic, For Endoscope 0

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

Disclaimer: MAUDE figures for Accessories, 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 Accessories, 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.