2026 data FDA MAUDE openFDA FDA Class II

Prosthesis, Rib Replacement

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).

FDA MAUDE casebook

openFDA event book Prosthesis, Rib Replacement LIGHT-BOOK · MAUDE

#651 of 1000 · 1,052 reports · 2005–2026

  • BOOK 1,052 reports
  • RANK #651 of 1000
  • DEATH 15 death-typed
  • INJ 907 injury-typed
  • MALF 127 malfunction
  • SPAN 2005–2026
  • PEAK 2015: 174
  • PHOTO Drill, Bone, Powered

Nearest event-volume peer: Drill, Bone, Powered (1 report gap)

Prosthesis, Rib Replacement sits #651 of 1000 among tracked device types with 1,052 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

Prosthesis, Rib Replacement carries 86.2% INJURY-coded reports, 55.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 86.2% corpus 30.3% · above corpus mean (+55.9 pp)
  • MALF 12.1% corpus 64.8% · below corpus mean (-52.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 35% of coded problems · Lead manufacturer SYNTHES BRANDYWINE accounts for 30% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Prosthesis, Rib Replacement in the event-volume neighbourhood

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

reports

What this shows Prosthesis, Rib Replacement carries 1,052 MAUDE reports, ranked #651 of 1000.

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

Event Types

Injury 907 (86.2%)
Malfunction 127 (12.1%)
Death 15 (1.4%)
3 (0.3%)

Patient Outcomes

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

Required Intervention 822 (78.2%)
202 (19.2%)
Death 17 (1.6%)
Other 6 (0.6%)
R 2 (0.2%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 368
Break 153
Migration or Expulsion of Device 126
Insufficient Device Problem Information 124
Patient Device Interaction Problem 47
Migration 38
Device Dislodged or Dislocated 35
Explanted 24
Device Operates Differently Than Expected 23
Material Integrity Problem 19
Unintended Movement 15
Appropriate Device Problem Term/Code Not Available 14
Replace 14
Detachment Of Device Component 13
Fracture 12
Device Slipped 8
Malposition of Device 8
Mechanical Problem 8
Material Separation 7
Unknown (for use when the device problem is not known) 7

Yearly Trend

05
2005: 2
06
2006: 1
07
2007: 2
08
2008: 16
09
2009: 29
10
2010: 14
11
2011: 38
12
2012: 157
13
2013: 78
14
2014: 109
15
2015: 174
16
2016: 31
17
2017: 64
18
2018: 37
19
2019: 136
20
2020: 4
21
2021: 94
22
2022: 27
23
2023: 4
24
2024: 20
25
2025: 1
26
2026: 14

Reports fell to 1 in 2025, down from an average of 12 in the two years before.

Related Entities for Prosthesis, Rib Replacement

Event Locations

644 (61.2%)
I 374 (35.6%)
HOSPITAL 29 (2.8%)
HOME 2 (0.2%)
NO INFORMATION 2 (0.2%)
UNKNOWN 1 (0.1%)

Compare SYNTHES BRANDYWINE vs SYNTHES USA →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis, Rib Replacement: 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 (1,052 here).

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis, Rib Replacement 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 Prosthesis, Rib Replacement; 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.