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2026 data FDA MAUDE openFDA FDA Class II

Posterior Metal/Polymer Spinal System, Fusion

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 §888.3070 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Posterior Metal/Polymer Spinal System LIGHT-BOOK · MAUDE

#711 of 1000 · 848 reports · 2005–2026

  • BOOK 848 reports
  • RANK #711 of 1000
  • DEATH 0 death-typed
  • INJ 624 injury-typed
  • MALF 193 malfunction
  • SPAN 2005–2026
  • PEAK 2010: 119
  • PHOTO Dislodger

Nearest event-volume peer: Dislodger, Stone, Biliary (1 report gap)

Posterior Metal/Polymer Spinal System, Fusion sits #711 of 1000 among tracked device types with 848 MAUDE reports spanning 2005–2026. 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

Posterior Metal/Polymer Spinal System carries 73.6% INJURY-coded reports, 43.3pp 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 73.6% corpus 30.3% · above corpus mean (+43.3 pp)
  • MALF 22.8% corpus 64.8% · below corpus mean (-42.1 pp)

Lead product-problem code Break is 33% of coded problems · Lead manufacturer ZIMMER GMBH accounts for 77% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Posterior Metal/Polymer Spinal System in the event-volume neighbourhood

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

reports

What this shows Posterior Metal/Polymer Spinal System, Fusion carries 848 MAUDE reports, ranked #711 of 1000.

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

Event Types

Injury 624 (73.6%)
Malfunction 193 (22.8%)
Other 26 (3.1%)
5 (0.6%)

Patient Outcomes

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

Required Intervention 294 (27.3%)
Hospitalization 233 (21.7%)
R 217 (20.2%)
181 (16.8%)
Other 136 (12.7%)
H 4 (0.4%)
O 3 (0.3%)
Disability 3 (0.3%)
S 2 (0.2%)
L 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Break 290
Implant breakage or physical damage 139
Insufficient Device Problem Information 89
Adverse Event Without Identified Device or Use Problem 46
Explanted 46
Device Slipped 45
Fracture 42
Loose or Intermittent Connection 39
Loose 28
Appropriate Device Problem Term/Code Not Available 16
Device Operates Differently Than Expected 15
Nonstandard Device 14
Malposition of Device 13
Migration or Expulsion of Device 13
Detachment Of Device Component 12
Difficult to Insert 10
Replace 10
Device remains implanted 7
Implant, removal of 6
Unknown (for use when the device problem is not known) 6

Yearly Trend

05
2005: 1
06
2006: 5
07
2007: 45
08
2008: 101
09
2009: 109
10
2010: 119
11
2011: 60
12
2012: 66
13
2013: 58
14
2014: 46
15
2015: 38
16
2016: 79
17
2017: 28
18
2018: 29
19
2019: 8
20
2020: 15
21
2021: 7
22
2022: 12
23
2023: 2
24
2024: 8
25
2025: 8
26
2026: 4

Reports rose to 8 in 2025, up from an average of 5 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Posterior Metal/Polymer Spinal System, Fusion

Top Manufacturers

ZIMMER GMBH 295
SYNTHES (USA) 42
MEDTRONIC SOFAMOR DANEK 16
ZIMMER, INC. 15
SYNTHES MONUMENT 14

Event Locations

532 (62.7%)
I 184 (21.7%)
HOSPITAL 103 (12.1%)
OTHER 22 (2.6%)
NO INFORMATION 4 (0.5%)
HOME 2 (0.2%)
INVALID DATA 1 (0.1%)

Compare ZIMMER GMBH vs SYNTHES (USA) →

Nationwide devices with a comparable report-volume footprint

Posterior Metal/Polymer Spinal System 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 (848 here).

Dislodger, Stone, Biliary 847 Incubator, Neonatal 847 Tubing, Fluid Delivery 850 Instruments, Surgical, Cardiovascular 845

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, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Posterior Metal/Polymer Spinal System 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 Posterior Metal/Polymer Spinal System; 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.