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2026 data FDA MAUDE openFDA FDA Class II

Intervertebral Fusion Device With Bone Graft, Cervical

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 §888.3080 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Intervertebral Fusion Device With Bone Graft LIGHT-BOOK · MAUDE

#639 of 1000 · 1,117 reports · 2008–2026

  • BOOK 1,117 reports
  • RANK #639 of 1000
  • DEATH 3 death-typed
  • INJ 664 injury-typed
  • MALF 440 malfunction
  • SPAN 2008–2026
  • PEAK 2021: 161
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Hemi-, Femoral, Metal Ball (3 report gap)

Intervertebral Fusion Device With Bone Graft, Cervical sits #639 of 1000 among tracked device types with 1,117 MAUDE reports spanning 2008–2026. 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 →

Injury-coded reports run above the device-type norm

Intervertebral Fusion Device With Bone Graft carries 59.4% INJURY-coded reports, 29.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 59.4% corpus 30.3% · above corpus mean (+29.2 pp)
  • MALF 39.4% corpus 64.8% · below corpus mean (-25.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer OBERDORF SYNTHES PRODUKTIONS GMBH accounts for 35% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Intervertebral Fusion Device With Bone Graft in the event-volume neighbourhood

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

reports

What this shows Intervertebral Fusion Device With Bone Graft, Cervical carries 1,117 MAUDE reports, ranked #639 of 1000.

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

Event Types

Injury 664 (59.4%)
Malfunction 440 (39.4%)
Other 6 (0.5%)
4 (0.4%)
Death 3 (0.3%)

Patient Outcomes

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

Required Intervention 553 (47.2%)
402 (34.3%)
Other 110 (9.4%)
R 30 (2.6%)
Hospitalization 30 (2.6%)
S 13 (1.1%)
Disability 13 (1.1%)
O 8 (0.7%)
H 6 (0.5%)
Death 3 (0.3%)
Life Threatening 3 (0.3%)
L 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 352
Break 192
Migration 80
Fracture 68
Migration or Expulsion of Device 61
Malposition of Device 47
Device Dislodged or Dislocated 44
Insufficient Device Problem Information 43
Detachment Of Device Component 30
Patient Device Interaction Problem 28
Device Slipped 19
Device Operates Differently Than Expected 17
Appropriate Device Problem Term/Code Not Available 16
No Apparent Adverse Event 16
Difficult to Remove 15
Improper or Incorrect Procedure or Method 15
Patient-Device Incompatibility 15
Positioning Problem 15
Material Deformation 13
Difficult to Insert 12

Yearly Trend

08
2008: 2
09
2009: 21
10
2010: 54
11
2011: 38
12
2012: 92
13
2013: 78
14
2014: 43
15
2015: 51
16
2016: 37
17
2017: 39
18
2018: 51
19
2019: 141
20
2020: 86
21
2021: 161
22
2022: 50
23
2023: 36
24
2024: 55
25
2025: 57
26
2026: 25

Reports in 2025 (57) held close to the prior two-year average of 46.

Related Entities for Intervertebral Fusion Device With Bone Graft, Cervical

Top Manufacturers

OBERDORF SYNTHES PRODUKTIONS GMBH 126
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 102
SYNTHES GMBH 53
SYNTHES USA 43
SYNTHES MONUMENT 36

Event Locations

596 (53.4%)
I 457 (40.9%)
HOSPITAL 47 (4.2%)
NO INFORMATION 13 (1.2%)
HOME 2 (0.2%)
OTHER 2 (0.2%)

Compare OBERDORF SYNTHES PRODUKTIONS GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Intervertebral Fusion Device With Bone Graft: 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 (1,117 here).

Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,120 Apparatus, Suction, Patient Care 1,122 Dilator, Catheter, Ureteral 1,108 Epidural Anesthesia Kit 1,130

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Intervertebral Fusion Device With Bone Graft 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 Intervertebral Fusion Device With Bone Graft; 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.