Arthrex® AR-8944CR-PRecalls & reported problems
Arthrex, Inc. · LO-PRO MTP PLT TM CONTRD,SHT,R,TI · 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 00888867052987), received between Feb 22, 2017 and Feb 22, 2017 — 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
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2017Break
IT WAS REPORTED THAT THE AR-8944CR-P WAS BEING USED IN A FIRST METATARSAL PHALANGEAL JOINT FUSION. THE PROCEDURE TOOK PLACE ON (B)(6) 2016, AND WAS COMPLETED SUCCESSFULLY. APPROXIMATELY 2-3 MONTHS AFTER THE PROCEDURE, THE PATIENT WAS WALKING AND FELT THE PLATE POP. SHE WAS ALSO FEELING A LITTLE DISCOMFORT. SHE WENT AND SAW THE DOCTOR WHO PERFORMED THE SURGERY SINCE SHE WAS CONCERNED SOMETHING BROKE. THE DOCTOR TOOK AN X-RAY AND CONFIRMED THAT THE PLATE WAS BROKEN IN HALF. A REVISION SURGERY WAS PERFORMED (B)(6) 2016 AND THIS PLATE WAS REMOVED. DURING THE SURGERY, THE SURGEON FELT THAT ANOTHER PLATE WAS NOT NECESSARY SINCE THE FUSION WAS COMPLETE. PATIENT IS DOING WELL POST OP.
Patient problems: Discomfort
MAUDE report 6349902 ↗
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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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