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2026 data FDA MAUDE openFDA FDA Class I

Expander, Surgical, Skin Graft

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 §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Expander, Surgical, Skin Graft LIGHT-BOOK · MAUDE

#309 of 1000 · 5,240 reports · 1992–2026

  • BOOK 5,240 reports
  • RANK #309 of 1000
  • DEATH 0 death-typed
  • INJ 266 injury-typed
  • MALF 4,971 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 605
  • PHOTO Sterilizer, Chemical

Nearest event-volume peer: Sterilizer, Chemical (2 report gap)

Expander, Surgical, Skin Graft sits #309 of 1000 among tracked device types with 5,240 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 →

Malfunction reports run above the device-type norm

Expander, Surgical, Skin Graft carries 94.9% MALFUNCTION-coded reports, 30.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
  • MALF 94.9% corpus 64.8% · above corpus mean (+30.0 pp)

Lead product-problem code Failure to Cut is 40% of coded problems · Lead manufacturer ZIMMER SURGICAL, INC. accounts for 99% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Expander, Surgical, Skin Graft in the event-volume neighbourhood

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

reports

What this shows Expander, Surgical, Skin Graft carries 5,240 MAUDE reports, ranked #309 of 1000.

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

Event Types

Malfunction 4,971 (94.9%)
Injury 266 (5.1%)
2 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

4,958 (94.8%)
Other 147 (2.8%)
Required Intervention 98 (1.9%)
R 19 (0.4%)
O 4 (0.1%)
Disability 3 (0.1%)
Invalid Data 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Failure to Cut 2,304
Material Twisted/Bent 958
Physical Resistance/Sticking 528
Device Operates Differently Than Expected 343
Appropriate Device Problem Term/Code Not Available 230
Bent 228
Break 139
Material Deformation 136
Mechanical Jam 123
Mechanical Problem 114
Naturally Worn 98
Retraction Problem 84
Failure to Advance 81
Fitting Problem 77
Insufficient Device Problem Information 72
Patient Device Interaction Problem 61
Component Missing 60
Difficult to Remove 59
Dull, Blunt 48
Calibration Problem 47

Yearly Trend

92
1992: 1
93
1993: 4
94
1994: 5
98
1998: 1
00
2000: 2
01
2001: 1
02
2002: 3
03
2003: 3
04
2004: 1
05
2005: 3
08
2008: 3
09
2009: 72
10
2010: 51
11
2011: 12
12
2012: 69
13
2013: 176
14
2014: 76
15
2015: 54
16
2016: 19
17
2017: 446
18
2018: 480
19
2019: 469
20
2020: 486
21
2021: 554
22
2022: 510
23
2023: 605
24
2024: 443
25
2025: 440
26
2026: 251

Reports in 2025 (440) held close to the prior two-year average of 524.

Related Entities for Expander, Surgical, Skin Graft

Top Manufacturers

ZIMMER SURGICAL, INC. 4,670
INTEGRA LIFESCIENCES CORPORATION OH/USA 40
SMITH & NEPHEW MEDICAL LTD. 7
SMITH & NEPHEW, INC. 5

Event Locations

2,847 (54.3%)
I 2,351 (44.9%)
HOSPITAL 30 (0.6%)
NO INFORMATION 5 (0.1%)
OTHER 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
INVALID DATA 1 (0.0%)

Compare ZIMMER SURGICAL, INC. vs INTEGRA LIFESCIENCES CORPORATION OH/USA →

Nationwide devices with a comparable report-volume footprint

Expander, Surgical, Skin Graft carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,240 here).

Sterilizer, Chemical 5,242 System, X-Ray, Tomography, Computed 5,243 Dilator, Esophageal 5,224 Light, Surgical, Ceiling Mounted 5,203

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Expander, Surgical, Skin Graft 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 Expander, Surgical, Skin Graft; 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.