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2025 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#873 of 1000 · 499 reports · 1994–2025

  • BOOK 499 reports
  • RANK #873 of 1000
  • DEATH 1 death-typed
  • INJ 367 injury-typed
  • MALF 34 malfunction
  • SPAN 1994–2025
  • PEAK 2016: 140
  • PHOTO Bronchial Thermoplast…

Nearest event-volume peer: Bronchial Thermoplasty System (1 report gap)

Bone Grafting Material, Synthetic sits #873 of 1000 among tracked device types with 499 MAUDE reports spanning 1994–2025. 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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 73.5% corpus 30.4% · above corpus mean (+43.1 pp)
  • MALF 6.8% corpus 64.5% · below corpus mean (-57.7 pp)

Lead product-problem code Insufficient Information is 50% of coded problems · Lead manufacturer INSTITUT STRAUMANN AG accounts for 100% of manufacturer-tagged reports · Top event location is 52% 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 499 MAUDE reports, ranked #873 of 1000.

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

Event Types

Injury 367 (73.5%)
Other 91 (18.2%)
Malfunction 34 (6.8%)
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 251 (44.4%)
Other 128 (22.7%)
Hospitalization 68 (12.0%)
R 57 (10.1%)
47 (8.3%)
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 Information 121
Failure to Osseointegrate 32
Adverse Event Without Identified Device or Use Problem 25
Osseointegration Problem 21
Patient-Device Incompatibility 9
Device Operates Differently Than Expected 5
Product Quality Problem 4
Appropriate Term/Code Not Available 3
Device Emits Odor 3
Migration or Expulsion of Device 3
Contamination 2
Loss of or Failure to Bond 2
Patient Device Interaction Problem 2
Shelf Life Exceeded 2
Component Missing 1
Device Appears to Trigger Rejection 1
Device Expiration Issue 1
Device Markings/Labelling Problem 1
Improper or Incorrect Procedure or Method 1
Loss of Osseointegration 1

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

Related Entities for Bone Grafting Material, Synthetic

Top Manufacturers

INSTITUT STRAUMANN AG 12

Event Locations

261 (52.3%)
I 206 (41.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Bone Grafting Material, Synthetic, 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 (499 here).

Bronchial Thermoplasty System 500 Prosthesis 498 Infusor, Pressure, For I.V. Bags 501 Apparatus, Traction, Non-Powered 502

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.