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2026 data FDA MAUDE openFDA

Instrument, Surgical, Disposable

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.

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FDA MAUDE casebook

openFDA event book Instrument, Surgical, Disposable LIGHT-BOOK · MAUDE

#691 of 1000 · 849 reports · 1993–2026

  • BOOK 849 reports
  • RANK #691 of 1000
  • DEATH 2 death-typed
  • INJ 147 injury-typed
  • MALF 685 malfunction
  • SPAN 1993–2026
  • PEAK 2013: 538
  • PHOTO Posterior Metal/Polym…

Nearest event-volume peer: Posterior Metal/Polymer Spinal System, Fusion (1 report gap)

Instrument, Surgical, Disposable sits #691 of 1000 among tracked device types with 849 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 →

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 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 17.3% corpus 30.4% · below corpus mean (-13.1 pp)
  • MALF 80.7% corpus 64.5% · above corpus mean (+16.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 40% of coded problems · Lead manufacturer DEPUY SYNTHES POWER TOOLS accounts for 46% of manufacturer-tagged reports · Top event location is 76% of location-tagged rows .

Instrument, Surgical, Disposable in the event-volume neighbourhood

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

reports

What this shows Instrument, Surgical, Disposable carries 849 MAUDE reports, ranked #691 of 1000.

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

Event Types

Malfunction 685 (80.7%)
Injury 147 (17.3%)
12 (1.4%)
Other 3 (0.4%)
Death 2 (0.2%)

Patient Outcomes

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

670 (77.4%)
Required Intervention 109 (12.6%)
Other 35 (4.0%)
Hospitalization 29 (3.3%)
R 11 (1.3%)
L 3 (0.3%)
Invalid Data 3 (0.3%)
Death 2 (0.2%)
H 1 (0.1%)
O 1 (0.1%)
S 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 69
Break 36
Material Separation 32
Unsealed Device Packaging 5
Defective Component 4
Delivered as Unsterile Product 3
Insufficient Information 3
Appropriate Term/Code Not Available 2
Contamination 2
Defective Device 2
Detachment Of Device Component 2
Material Integrity Problem 2
Migration 2
Torn Material 2
Use of Device Problem 2
Component Falling 1
Connection Problem 1
Crack 1
Device Contaminated During Manufacture or Shipping 1
Device Contamination with Chemical or Other Material 1

Yearly Trend

93
1993: 12
94
1994: 38
95
1995: 7
05
2005: 2
07
2007: 2
08
2008: 7
10
2010: 9
11
2011: 6
12
2012: 12
13
2013: 538
14
2014: 17
15
2015: 15
16
2016: 11
17
2017: 9
18
2018: 71
19
2019: 16
20
2020: 13
21
2021: 11
22
2022: 10
23
2023: 15
24
2024: 14
25
2025: 7
26
2026: 7

Related Entities for Instrument, Surgical, Disposable

Top Manufacturers

DEPUY SYNTHES POWER TOOLS 320
THE ANSPACH EFFORT, INC. 169
ETHICON INC. 126
SMITH & NEPHEW, INC. 25
HOSPIRA COSTA RICA LTD. 21
ETHICON ENDO-SURGERY 18
UNITED STATES SURGICAL CORP. 18

Event Locations

646 (76.1%)
I 121 (14.3%)
HOSPITAL 60 (7.1%)
INVALID DATA 14 (1.6%)
NO INFORMATION 6 (0.7%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare DEPUY SYNTHES POWER TOOLS vs THE ANSPACH EFFORT, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, Surgical, Disposable, 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 (849 here).

Posterior Metal/Polymer Spinal System 848 Laparoscopic Contraceptive Tubal Occlusion… 847 Digital Breast Tomosynthesis 846 Heat-Exchanger, Cardiopulmonary Bypass 845

Similar death-typed counts

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

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

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

Disclaimer: MAUDE figures for Instrument, Surgical, Disposable 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 Instrument, Surgical, Disposable; 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.