NEUFLEX 1234-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295017981), received between Aug 4, 2017 and Dec 20, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2017Fracture; Fracture

  MEDWATCH REPORT RECEIVED STATED THAT MCP IMPLANT PLACED RIGHT INDEX MP SILASTIC ARTHROPLASTY. PATIENT EXPERIENCED SYMPTOM RELIEF A COUPLE OF MONTHS AFTER. LATER IN THE YEAR, XRAYS REVIEWED ARTHROPLASTY WELL INCORPORATED. SIGNIFICANT ARTHRITIS WITH DEVIATION NOTED AT RIP JOINT. PATIENT SEEN WITH DOCTOR, WHO REVIEWED TREATMENT OPTIONS INCLUDING PIP JOINT FUSION VS WORKING WITH HAND OT TO SEE HOW MUCH MOBILITY CAN RECOVERED. DOCTOR WARNED THAT PATIENT MAY DEVELOP INCREASE PAIN AT HER PIP JOINT WHILE WORKING ON ROM BUT PATIENT IS INTERESTED IN PROCEEDING. PLAN FOR RETURN TO CLINIC IN 2 MONTHS. PATIENT RETURNED WITH INCREASED PAIN AND SWELLING. FLUOROSCOPIC IMAGING OBTAIN TODAY SHOWS THE IMPLANT APPEARS WELL SEATED IN THE PROXIMAL PHALANX AND METACARPAL WITH NO EVIDENCE OF OSTEOLYSIS. HOWEVER IT LOOKS AS THOUGH THE IMPLANT MAY BE BROKEN AT HINGE. DOI: (B)(6) 2016; DOR: (B)(6) 2017 AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling

  MAUDE report 7133910 ↗
• InjuryAug 4, 2017Break; Break

  DER STATES THAT PATIENT IS VERY ACTIVE IN HORSEBACK RIDING, CLEANING STALLS, ETC. SURGEON FELT PATIENT HAD DISRUPTED HER COLLATERAL LIGAMENTS AND TOOK IN FOR REPAIR. SURGEON FOUND DISRUPTED COLLATERALS BUT ALSO 3 OF 4 MCP NUFLEX IMPLANTS (INDEX, MIDDLE, RING) HAD BROKEN AT THE POST. TWO OF THESE (INDEX/MIDDLE) HAD BEEN IMPLANTED ON (B)(6) 2013. THE RING SURGEON HAD REVISED AND IMPLANTED NEW ON (B)(6) 2016. SURGEON. BELIEVED IMPLANT FAILURE DUE TO IMPLANT POSTPONING EXASPERATED BY COLLATERAL LIGAMENT FAILURE.

  Patient problems: No Information

  MAUDE report 6766969 ↗
• InjuryAug 4, 2017Break; Break

  DER STATES THAT PATIENT IS VERY ACTIVE IN HORSEBACK RIDING, CLEANING STALLS, ETC. SURGEON FELT PATIENT HAD DISRUPTED HER COLLATERAL LIGAMENTS AND TOOK IN FOR REPAIR. SURGEON FOUND DISRUPTED COLLATERALS BUT ALSO 3 OF 4 MCP NUFLEX IMPLANTS (INDEX, MIDDLE, RING) HAD BROKEN AT THE POST. TWO OF THESE (INDEX/MIDDLE) HAD BEEN IMPLANTED ON (B)(6) 2013. THE RING SURGEON HAD REVISED AND IMPLANTED NEW ON (B)(6) 2016. SURGEON. BELIEVED IMPLANT FAILURE DUE TO IMPLANT POSTPONING EXASPERATED BY COLLATERAL LIGAMENT FAILURE.

  Patient problems: No Code Available

  MAUDE report 6766939 ↗