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2026 data FDA MAUDE openFDA

Implant, Endosseous, Root-Form

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.

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FDA MAUDE casebook

openFDA event book Implant, Endosseous, Root-Form HEAVY-BOOK · MAUDE

#1 of 1000 · 3,537,615 reports · 1993–2026

  • BOOK 3,537,615 reports
  • RANK #1 of 1000
  • DEATH 42 death-typed
  • INJ 3,507,501 injury-typed
  • MALF 29,392 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 745,835
  • PHOTO Integrated Continuous…

Nearest event-volume peer: Integrated Continuous Glucose Monitoring System, Factory Calibrated (1,624,306 report gap)

Implant, Endosseous, Root-Form sits #1 of 1000 among tracked device types with 3,537,615 MAUDE reports spanning 1993–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 99.1% corpus 30.4% · above corpus mean (+68.7 pp)
  • MALF 0.8% corpus 64.5% · below corpus mean (-63.7 pp)

Lead product-problem code Failure to Osseointegrate is 62% of coded problems · Lead manufacturer INSTITUT STRAUMANN AG accounts for 39% of manufacturer-tagged reports · Top event location OTHER is 38% of location-tagged rows .

Implant, Endosseous, Root-Form in the event-volume neighbourhood

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

reports

What this shows Implant, Endosseous, Root-Form carries 3,537,615 MAUDE reports, ranked #1 of 1000.

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

Event Types

Injury 3,507,501 (99.1%)
Malfunction 29,392 (0.8%)
Other 581 (0.0%)
99 (0.0%)
Death 42 (0.0%)

Patient Outcomes

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

Required Intervention 3,462,031 (97.2%)
Other 32,177 (0.9%)
27,869 (0.8%)
R 16,096 (0.5%)
O 5,671 (0.2%)
Congenital Anomaly 4,448 (0.1%)
Disability 3,147 (0.1%)
S 2,855 (0.1%)
H 1,501 (0.0%)
Hospitalization 1,343 (0.0%)
L 1,198 (0.0%)
D 580 (0.0%)
C 535 (0.0%)
Life Threatening 450 (0.0%)
Death 115 (0.0%)

Top Product Problems

Failure to Osseointegrate 2,192,767
Loss of Osseointegration 788,533
Osseointegration Problem 285,498
Adverse Event Without Identified Device or Use Problem 124,300
Fracture 57,159
Use of Device Problem 24,373
Difficult to Insert 12,771
Patient Device Interaction Problem 10,465
Insufficient Information 6,460
Migration 4,914
Separation Failure 4,740
Positioning Failure 3,888
Malposition of Device 3,073
Premature Separation 2,563
Material Deformation 2,302
Positioning Problem 2,040
Mechanical Problem 1,941
Loosening of Implant Not Related to Bone-Ingrowth 1,661
Unintended Movement 1,333
Activation, Positioning or Separation Problem 1,288

Yearly Trend

93
1993: 204
94
1994: 795
95
1995: 966
96
1996: 4,066
97
1997: 7,448
98
1998: 1,953
99
1999: 223
00
2000: 13
01
2001: 40
02
2002: 32
03
2003: 91
04
2004: 100
05
2005: 69
06
2006: 605
07
2007: 225
08
2008: 393
09
2009: 164
10
2010: 360
11
2011: 362
12
2012: 358
13
2013: 391
14
2014: 1,124
15
2015: 2,894
16
2016: 1,116
17
2017: 9,719
18
2018: 12,892
19
2019: 167,016
20
2020: 255,524
21
2021: 479,619
22
2022: 483,224
23
2023: 537,585
24
2024: 697,102
25
2025: 745,835
26
2026: 125,107

Related Entities for Implant, Endosseous, Root-Form

Top Manufacturers

INSTITUT STRAUMANN AG 1,087,236
NOBEL BIOCARE AB 883,316
JJGC S.A. 193,687
DENTSPLY IMPLANTS MANUFACTURING GMBH 152,933
NOBEL BIOCARE USA INC 122,529
MIS IMPLANTS TECHNOLOGIES LTD. 111,785
DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) 81,111
ALTATEC GMBH 79,289
BIOHORIZONS IMPLANT SYSTEMS 57,540

Event Locations

OTHER 1,333,132 (37.7%)
1,132,253 (32.0%)
OUTPATIENT TREATMENT FACILITY 618,903 (17.5%)
I 445,402 (12.6%)
NO INFORMATION 3,358 (0.1%)
AMBULATORY SURGICAL FACILITY 1,792 (0.1%)
INVALID DATA 1,613 (0.0%)
UNKNOWN 812 (0.0%)
HOSPITAL 182 (0.0%)
NOT APPLICABLE 79 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 52 (0.0%)
HOME 35 (0.0%)
NURSING HOME 2 (0.0%)

Compare INSTITUT STRAUMANN AG vs NOBEL BIOCARE AB →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Implant, Endosseous, Root-Form, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,537,615 here).

Integrated Continuous Glucose Monitoring Sy… 1,913,309 Pump, Infusion 1,803,616 Alternate Controller Enabled Insulin Infusi… 1,088,188 Pump 886,701

Similar death-typed counts

Nearest other device types by death-typed report count (42 here), distinct from the volume row.

Catheters, Suction, Tracheobronchial 42 Nebulizer 42 Bath, Hydro-Massage 43 Bed, Flotation Therapy, Powered 41

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

Disclaimer: MAUDE figures for Implant, Endosseous, Root-Form 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 Implant, Endosseous, Root-Form; 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.