Reported Reactions

Devices › Expander, surgical, skin graft

Device brand name · Expander surgical skin graft

Zimmer Skin Graft Mesher: medical device reports filed with FDA

3,463 reports name it, 2009–2026. Manufacturer given most often on reports: Zimmer Surgical. Product code FZW.

3,463
device reports naming the brand
0% of all MAUDE reports · about 203 a year
285
reports, 12 months to August 2026
300 in the 12 months before
96%
classified as malfunction
94.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 3,463 reports that name the brand "Zimmer Skin Graft Mesher" (expander surgical skin graft), received between June 2009 and August 2026; the manufacturer given most often on reports is Zimmer Surgical. Spellings of one product vary from report to report.

285 reports arrived in the 12 months to August 2026, close to the 300 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96%) and injury (4%); across all expander, surgical, skin graft reports (product code FZW) death is recorded in 0% and malfunction in 94.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to cut (31.7%), material twisted/bent (26%) and physical resistance/sticking (12.7%). The patient problems coded most often are no patient involvement, abrasion and tissue damage. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

02039Sep 2021: 17Oct 2021: 22Nov 2021: 23Dec 2021: 242022Jan 2022: 17Feb 2022: 12Mar 2022: 22Apr 2022: 25May 2022: 38Jun 2022: 22Jul 2022: 13Aug 2022: 23Sep 2022: 19Oct 2022: 23Nov 2022: 15Dec 2022: 112023Jan 2023: 23Feb 2023: 31Mar 2023: 32Apr 2023: 23May 2023: 12Jun 2023: 27Jul 2023: 19Aug 2023: 16Sep 2023: 22Oct 2023: 21Nov 2023: 27Dec 2023: 382024Jan 2024: 24Feb 2024: 21Mar 2024: 27Apr 2024: 24May 2024: 26Jun 2024: 21Jul 2024: 31Aug 2024: 22Sep 2024: 29Oct 2024: 23Nov 2024: 27Dec 2024: 182025Jan 2025: 20Feb 2025: 19Mar 2025: 31Apr 2025: 27May 2025: 21Jun 2025: 23Jul 2025: 39Aug 2025: 23Sep 2025: 29Oct 2025: 23Nov 2025: 20Dec 2025: 172026Jan 2026: 20Feb 2026: 24Mar 2026: 25Apr 2026: 25May 2026: 23Jun 2026: 24Jul 2026: 31Aug 2026: 24

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

01863712009: 5520092010: 282011: 2020112012: 582013: 16420132014: 922015: 1720152016: 92017: 34120172018: 3662019: 37120192020: 3562021: 27420212022: 2402023: 29120232024: 2932025: 29220252026: 196

Event type and report source

Event type, as classified on the report

Death0%0
Injury4%139
Malfunction96%3,324
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%3,462
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%1

Grey bar: all 5,270 reports carrying product code FZW. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to cut1,09731.7%43.9%
Material twisted/bent90126%18.2%
Physical resistance/sticking44112.7%10.1%
Bent2557.4%4.3%
Device operates differently than expectedthe device behaved unexpectedly2507.2%6.5%
Breakthe device broke1464.2%2.6%
Mechanical jam1053%2.3%
Material deformation902.6%2.6%
Mechanical problema mechanical problem892.6%2.2%
Retraction problem802.3%1.7%
Failure to advance712.1%1.5%
Fitting problem702%1.4%
Naturally worn621.8%1.9%
Difficult to removethe device was hard to remove501.4%1.1%
Insufficient device problem information461.3%1.3%
Component missing441.3%1.1%
Sticking371.1%0.6%
Patient device interaction problem240.7%1.1%
Difficult to open or close210.6%0.4%
Difficult to advance200.6%0.4%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
No patient involvement47513.7%
Abrasion471.4%
Tissue damage341%
Laceration(s)331%
Skin tears280.8%
Graft failure110.3%
Complaint, ill-defined20.1%
Failure of implant10%
Injurya physical injury10%
Painpain, site not specified10%
Physical entrapment10%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureZimmer Skin Graft MesherProduct code FZWAll MAUDE reports
Reports3,4635,27026,136,888
Share of that pool—65.7%0%
Classified as death, per 1,000 reports009
Classified as injury4%5%36.2%
Classified as malfunction96%94.9%62.3%
Filed by the manufacturer100%99.4%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code FZW

BrandReportsLatest 12 monthsClassified as death
Z S G M Cutter 1 5 1 Ratio Caution Sharp342170%
Z S G M Cutter 2 1 Ratio Caution Sharp22060%
Padgett Model S Slimline Electric Dermatome24700%
Zimmer Air Dermatome2,6873720%
Air Dermatome Handpiece51100%
Dermatome AN Handpiece4461170%
Fan Spray Kit8501730%
Handpiece Electric Dermatome1,8251740%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Zimmer Skin Graft Mesher reports

How many FDA reports name Zimmer Skin Graft Mesher?

3,463 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 285 in the latest 12 months.

What kinds of events are reported?

malfunction (96%) and injury (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to cut (31.7%), material twisted/bent (26%), physical resistance/sticking (12.7%), bent (7.4%) and device operates differently than expected (7.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Zimmer Skin Graft Mesher was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.