2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §888.3020 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Rod MID-BOOK · MAUDE

#93 of 1000 · 37,471 reports · 1992–2026

  • BOOK 37,471 reports
  • RANK #93 of 1000
  • DEATH 115 death-typed
  • INJ 24,831 injury-typed
  • MALF 12,386 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 4,111
  • PHOTO Hexokinase, Glucose

Nearest event-volume peer: Hexokinase, Glucose (63 report gap)

Rod, Fixation, Intramedullary And Accessories sits #93 of 1000 among tracked device types with 37,471 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 →

Injury-coded reports run above the device-type norm

Rod carries 66.3% INJURY-coded reports, 36.0pp 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 66.3% corpus 30.3% · above corpus mean (+36.0 pp)
  • MALF 33.1% corpus 64.8% · below corpus mean (-31.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 25% of manufacturer-tagged reports · Top event location is 53% 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 37,471 MAUDE reports, ranked #93 of 1000.

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

Event Types

Injury 24,831 (66.3%)
Malfunction 12,386 (33.1%)
Death 115 (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 17,148 (40.6%)
11,250 (26.6%)
Other 4,482 (10.6%)
Hospitalization 4,098 (9.7%)
R 3,771 (8.9%)
H 899 (2.1%)
Death 304 (0.7%)
O 187 (0.4%)
S 60 (0.1%)
Disability 53 (0.1%)
L 12 (0.0%)
Congenital Anomaly 7 (0.0%)
Life Threatening 6 (0.0%)
D 3 (0.0%)
C 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 9,330
Break 8,211
Fracture 3,030
Device-Device Incompatibility 2,950
Migration 2,292
Migration or Expulsion of Device 1,139
Device Operates Differently Than Expected 1,036
Insufficient Device Problem Information 1,020
Appropriate Device Problem Term/Code Not Available 841
Failure to Align 723
Explanted 513
Material Twisted/Bent 498
Material Deformation 419
Mechanical Jam 418
Difficult to Insert 372
Device Dislodged or Dislocated 362
Malposition of Device 353
Mechanical Problem 330
Difficult to Remove 315
Fitting Problem 293

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: 2,933
26
2026: 1,303

Reports in 2025 (2,933) held close to the prior two-year average of 2,544.

Related Entities for Rod, Fixation, Intramedullary And Accessories

Event Locations

19,969 (53.3%)
I 16,771 (44.8%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Rod: 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 (37,471 here).

Similar death-typed counts

Nearest other device types by death-typed report count (115 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.