2026 data FDA MAUDE openFDA

Rod, Fixation, Intramedullary And Accessories

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 MAUDE casebook

openFDA event book Rod MID-BOOK · MAUDE

#92 of 1000 · 36,507 reports · 1992–2026

  • BOOK 36,507 reports
  • RANK #92 of 1000
  • DEATH 112 death-typed
  • INJ 24,335 injury-typed
  • MALF 11,921 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 4,111
  • PHOTO Replacement Heart-Val…

Nearest event-volume peer: Replacement Heart-Valve (101 report gap)

Rod, Fixation, Intramedullary And Accessories sits #92 of 1000 among tracked device types with 36,507 MAUDE reports spanning 1992–2026. 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 66.7% corpus 30.4% · above corpus mean (+36.2 pp)
  • MALF 32.7% corpus 64.5% · below corpus mean (-31.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 32% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 24% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Rod in the event-volume neighbourhood

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

reports

What this shows Rod, Fixation, Intramedullary And Accessories carries 36,507 MAUDE reports, ranked #92 of 1000.

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

Event Types

Injury 24,335 (66.7%)
Malfunction 11,921 (32.7%)
Death 112 (0.3%)
Other 107 (0.3%)
32 (0.1%)

Patient Outcomes

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

Required Intervention 16,802 (40.8%)
10,833 (26.3%)
Other 4,410 (10.7%)
Hospitalization 4,032 (9.8%)
R 3,703 (9.0%)
H 814 (2.0%)
Death 303 (0.7%)
O 185 (0.4%)
S 58 (0.1%)
Disability 53 (0.1%)
L 12 (0.0%)
Congenital Anomaly 7 (0.0%)
Life Threatening 6 (0.0%)
D 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 8,582
Break 5,573
Device-Device Incompatibility 2,826
Migration 2,216
Fracture 2,174
Migration or Expulsion of Device 662
Appropriate Term/Code Not Available 616
Insufficient Information 516
Failure to Align 500
Material Twisted/Bent 448
Device Operates Differently Than Expected 398
Material Deformation 353
Mechanical Problem 291
Mechanical Jam 279
Packaging Problem 277
Device Contaminated During Manufacture or Shipping 276
Unintended Movement 211
Delivered as Unsterile Product 205
Malposition of Device 175
Use of Device Problem 166

Yearly Trend

92
1992: 6
93
1993: 15
94
1994: 19
95
1995: 24
96
1996: 53
97
1997: 92
98
1998: 74
99
1999: 51
00
2000: 43
01
2001: 38
02
2002: 57
03
2003: 76
04
2004: 61
05
2005: 78
06
2006: 114
07
2007: 162
08
2008: 184
09
2009: 334
10
2010: 454
11
2011: 662
12
2012: 1,079
13
2013: 1,773
14
2014: 1,474
15
2015: 1,671
16
2016: 1,920
17
2017: 1,447
18
2018: 3,526
19
2019: 2,517
20
2020: 3,299
21
2021: 4,111
22
2022: 2,733
23
2023: 2,219
24
2024: 2,869
25
2025: 2,932
26
2026: 340

Related Entities for Rod, Fixation, Intramedullary And Accessories

Event Locations

19,005 (52.1%)
I 16,771 (45.9%)
HOSPITAL 551 (1.5%)
NO INFORMATION 65 (0.2%)
HOME 40 (0.1%)
UNKNOWN 29 (0.1%)
INVALID DATA 23 (0.1%)
OTHER 15 (0.0%)
NOT APPLICABLE 4 (0.0%)
NURSING HOME 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare SYNTHES GMBH vs STRYKER TRAUMA KIEL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Rod, 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 (36,507 here).

Similar death-typed counts

Nearest other device types by death-typed report count (112 here), distinct from the volume row.

Disclaimer: MAUDE figures for Rod 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 Rod; 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.