2026 data FDA MAUDE openFDA FDA Class I

Rongeur

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §888.4540 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Rongeur LIGHT-BOOK · MAUDE

#820 of 1000 · 615 reports · 1993–2026

  • BOOK 615 reports
  • RANK #820 of 1000
  • DEATH 2 death-typed
  • INJ 123 injury-typed
  • MALF 449 malfunction
  • SPAN 1993–2026
  • PEAK 2008: 59
  • PHOTO Container

Nearest event-volume peer: Container, Empty, For Collection & Processing Of Blood & Blood Components (0 report gap)

Rongeur sits #820 of 1000 among tracked device types with 615 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm

Rongeur carries 20.0% INJURY-coded reports, 10.3pp below 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 20.0% corpus 30.3% · below corpus mean (-10.3 pp)
  • MALF 73.0% corpus 64.8% · above corpus mean (+8.2 pp)

Lead product-problem code Break is 39% of coded problems · Lead manufacturer AESCULAP AG accounts for 38% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

Rongeur in the event-volume neighbourhood

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

reports

What this shows Rongeur carries 615 MAUDE reports, ranked #820 of 1000.

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

Event Types

Malfunction 449 (73.0%)
Injury 123 (20.0%)
Other 26 (4.2%)
15 (2.4%)
Death 2 (0.3%)

Patient Outcomes

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

392 (62.2%)
Other 112 (17.8%)
Required Intervention 90 (14.3%)
R 11 (1.7%)
Hospitalization 9 (1.4%)
Disability 5 (0.8%)
S 3 (0.5%)
O 2 (0.3%)
Life Threatening 2 (0.3%)
H 1 (0.2%)
L 1 (0.2%)
Death 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Break 289
Detachment Of Device Component 83
Tip breakage 59
Device, or device fragments remain in patient 39
Fracture 32
Component Missing 30
Component Falling 27
Material Fragmentation 25
Component(s), broken 23
Material Separation 21
Device Or Device Fragments Location Unknown 20
Device, removal of (non-implant) 18
Detachment of Device or Device Component 17
Bent 12
Material Integrity Problem 11
Replace 10
Difficult to Remove 9
Sticking 8
Appropriate Device Problem Term/Code Not Available 7
Material Deformation 7

Yearly Trend

93
1993: 1
94
1994: 3
95
1995: 4
96
1996: 5
97
1997: 12
98
1998: 15
99
1999: 5
00
2000: 9
01
2001: 10
02
2002: 8
03
2003: 9
04
2004: 11
05
2005: 14
06
2006: 15
07
2007: 21
08
2008: 59
09
2009: 28
10
2010: 18
11
2011: 22
12
2012: 13
13
2013: 34
14
2014: 15
15
2015: 38
16
2016: 28
17
2017: 26
18
2018: 25
19
2019: 24
20
2020: 29
21
2021: 26
22
2022: 23
23
2023: 14
24
2024: 24
25
2025: 16
26
2026: 11

Reports in 2025 (16) held close to the prior two-year average of 19.

Related Entities for Rongeur

Event Locations

291 (47.3%)
HOSPITAL 155 (25.2%)
I 131 (21.3%)
INVALID DATA 15 (2.4%)
NO INFORMATION 15 (2.4%)
OTHER 4 (0.7%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
NOT APPLICABLE 2 (0.3%)

Compare AESCULAP AG vs DEPUY SPINE INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Rongeur: 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 (615 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Rongeur 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 Rongeur; 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.