PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Bone Grafting Material, Synthetic

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 §872.3930 (Dental panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Bone Grafting Material, Synthetic LIGHT-BOOK · MAUDE

#886 of 1000 · 505 reports · 1994–2026

  • BOOK 505 reports
  • RANK #886 of 1000
  • DEATH 1 death-typed
  • INJ 372 injury-typed
  • MALF 35 malfunction
  • SPAN 1994–2026
  • PEAK 2016: 140
  • PHOTO Extracorporeal System…

Nearest event-volume peer: Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure (0 report gap)

Bone Grafting Material, Synthetic sits #886 of 1000 among tracked device types with 505 MAUDE reports spanning 1994–2026. 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 sit below the device-type norm

Bone Grafting Material, Synthetic carries 6.9% MALFUNCTION-coded reports, 57.9pp below 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 73.7% corpus 30.3% · above corpus mean (+43.4 pp)
  • MALF 6.9% corpus 64.8% · below corpus mean (-57.9 pp)

Lead product-problem code Insufficient Device Problem Information is 34% of coded problems · Lead manufacturer INSTITUT STRAUMANN AG accounts for 100% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Bone Grafting Material, Synthetic in the event-volume neighbourhood

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

reports

What this shows Bone Grafting Material, Synthetic carries 505 MAUDE reports, ranked #886 of 1000.

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

Event Types

Injury 372 (73.7%)
Other 91 (18.0%)
Malfunction 35 (6.9%)
6 (1.2%)
Death 1 (0.2%)

Patient Outcomes

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

Required Intervention 252 (44.1%)
Other 133 (23.3%)
Hospitalization 68 (11.9%)
R 57 (10.0%)
47 (8.2%)
O 5 (0.9%)
S 3 (0.5%)
Death 2 (0.4%)
Disability 2 (0.4%)
H 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Insufficient Device Problem Information 166
Failure to Osseointegrate 63
Adverse Event Without Identified Device or Use Problem 36
Device remains implanted 34
Unknown (for use when the device problem is not known) 28
Explanted 25
Osseointegration Problem 21
Patient-Device Incompatibility 17
Device Operates Differently Than Expected 16
Replace 15
Loose 8
Nonstandard Device 8
Reaction 8
Loss of or Failure to Bond 7
Migration or Expulsion of Device 7
Use of Device Problem 6
Appropriate Device Problem Term/Code Not Available 5
Detachment Of Device Component 5
Device Emits Odor 5
Device Issue 5

Yearly Trend

94
1994: 2
95
1995: 1
96
1996: 4
97
1997: 4
98
1998: 3
99
1999: 2
00
2000: 4
01
2001: 5
02
2002: 2
03
2003: 1
04
2004: 10
05
2005: 28
06
2006: 38
07
2007: 23
08
2008: 25
09
2009: 25
10
2010: 28
11
2011: 21
12
2012: 10
13
2013: 12
14
2014: 9
15
2015: 14
16
2016: 140
17
2017: 19
18
2018: 14
19
2019: 15
20
2020: 5
21
2021: 12
22
2022: 6
23
2023: 9
24
2024: 6
25
2025: 2
26
2026: 6

Reports fell to 2 in 2025, down from an average of 8 in the two years before.

Related Entities for Bone Grafting Material, Synthetic

Top Manufacturers

INSTITUT STRAUMANN AG 12

Event Locations

267 (52.9%)
I 206 (40.8%)
OTHER 7 (1.4%)
HOME 5 (1.0%)
NO INFORMATION 4 (0.8%)
UNKNOWN 4 (0.8%)
INVALID DATA 3 (0.6%)
HOSPITAL 2 (0.4%)
NOT APPLICABLE 2 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.4%)
OUTPATIENT TREATMENT FACILITY 2 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bone Grafting Material, Synthetic: 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 (505 here).

Extracorporeal System For Long-Term Respira… 505 Gases Used Within Eye To Place Pressure On… 504 Stylet, Tracheal Tube 506 Infusor, Pressure, For I.V. Bags 508

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Bone Grafting Material, Synthetic 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 Bone Grafting Material, Synthetic; 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.