Arthrex® AR-8008-25Recalls & reported problems
Arthrex, Inc. · 4 HOLE DBL COMP PLT,STR,25MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867042544), received between Dec 1, 2016 and Dec 1, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2016Break
IT WAS REPORTED THAT ON (B)(6) 2016 THE AR-8008-25, 4 HOLE DOUBLE COMPRESSION PLATE, WAS IMPLANTED. APPROXIMATELY 5 (FIVE) WEEKS AFTER INITIAL SURGERY, THE PLATE BROKE POST-OP. A REVISION SURGERY WAS DONE ON (B)(6) 2016 WHERE AN ARTHODESIS WAS PERFORMED WITH COMPRESSION SCREWS. PER SURGEON, THE PATIENT STATED THAT HE MIGHT HAVE HAD TOO MUCH WEIGHT ON THE FOOT TOO EARLY. BONE QUALITY UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 6138118 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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