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2026 data FDA MAUDE openFDA FDA Class I

Dermatome

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 §878.4820 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Dermatome LIGHT-BOOK · MAUDE

#242 of 1000 · 8,121 reports · 1992–2026

  • BOOK 8,121 reports
  • RANK #242 of 1000
  • DEATH 1 death-typed
  • INJ 1,596 injury-typed
  • MALF 6,431 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 806
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) (11 report gap)

Dermatome sits #242 of 1000 among tracked device types with 8,121 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

Dermatome carries 79.2% MALFUNCTION-coded reports, 14.4pp 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 19.7% corpus 30.3% · below corpus mean (-10.6 pp)
  • MALF 79.2% corpus 64.8% · above corpus mean (+14.4 pp)

Lead product-problem code Failure to Cut is 27% of coded problems · Lead manufacturer ZIMMER SURGICAL, INC. accounts for 95% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Dermatome in the event-volume neighbourhood

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

reports

What this shows Dermatome carries 8,121 MAUDE reports, ranked #242 of 1000.

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

Event Types

Malfunction 6,431 (79.2%)
Injury 1,596 (19.7%)
Other 63 (0.8%)
30 (0.4%)
Death 1 (0.0%)

Patient Outcomes

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

6,752 (81.6%)
Other 740 (8.9%)
Required Intervention 570 (6.9%)
R 127 (1.5%)
O 36 (0.4%)
Hospitalization 27 (0.3%)
Disability 9 (0.1%)
S 3 (0.0%)
Congenital Anomaly 3 (0.0%)
Death 2 (0.0%)
H 1 (0.0%)
L 1 (0.0%)

Top Product Problems

Failure to Cut 2,199
Device Operates Differently Than Expected 1,147
Unstable 519
Power Problem 506
Gas/Air Leak 398
Patient Device Interaction Problem 382
Appropriate Device Problem Term/Code Not Available 379
Intermittent Loss of Power 295
Calibration Problem 249
Mechanical Problem 248
Noise, Audible 220
Failure to Power Up 197
Material Frayed 187
Break 182
Material Deformation 180
Naturally Worn 168
Device Inoperable 162
Component Missing 154
Loss of Power 149
Insufficient Device Problem Information 142

Yearly Trend

92
1992: 8
93
1993: 1
94
1994: 12
95
1995: 5
96
1996: 14
97
1997: 17
98
1998: 16
99
1999: 20
00
2000: 25
01
2001: 24
02
2002: 14
03
2003: 70
04
2004: 63
05
2005: 32
06
2006: 32
07
2007: 30
08
2008: 32
09
2009: 266
10
2010: 169
11
2011: 226
12
2012: 258
13
2013: 558
14
2014: 365
15
2015: 195
16
2016: 125
17
2017: 324
18
2018: 378
19
2019: 472
20
2020: 433
21
2021: 614
22
2022: 545
23
2023: 806
24
2024: 796
25
2025: 760
26
2026: 416

Reports in 2025 (760) held close to the prior two-year average of 801.

Related Entities for Dermatome

Top Manufacturers

ZIMMER SURGICAL, INC. 5,390
INTEGRA LIFESCIENCES CORPORATION OH/USA 251
ZIMMER, INC. 33

Event Locations

5,514 (67.9%)
I 2,192 (27.0%)
HOSPITAL 372 (4.6%)
NO INFORMATION 25 (0.3%)
OTHER 9 (0.1%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
INVALID DATA 4 (0.0%)
UNKNOWN 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dermatome: 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 (8,121 here).

Prosthesis, Knee, Hemi-, Tibial, Resurfacing 8,110 Accessories, Soft Lens Products 8,031 Set 8,011 Lens, Intraocular, Toric Optics 7,999

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Dermatome 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 Dermatome; 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.