NA 626675Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327088656), received between Aug 5, 2020 and Oct 12, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• InjuryOct 12, 2020Fracture; Fracture

  AS REPORTED: "PATIENT UNDERGOING SURGICAL TREATMENT SHORTENING OF THE ULNAR IN ORDER TO TREAT ULNO-CARPAL IMPACT FOR 45 DAYS. PATIENT UNDERWENT WEEKLY FOLLOW-UP WITH FREQUENT RADIOGRAPHS, THE LAST ONE ON (B)(6) 2020 - OBSERVING OSTEOTOMY WITHOUT SIGNS OF CONSOLIDATION AND SYNTHESIS MATERIAL WITHOUT SIGNS OF FAILURE, HOWEVER THE X-RAY PERFORMED ON (B)(6) 2020 PRESENTED OSTEOTOMY WITHOUT SIGNS OF CONSOLIDATION AND FAILURE OF THE SYNTHESIS MATERIAL. HELD ON (B)(6) 2020, EMERGENCY PROCEDURE FOR NEW FIXATION OF THE OSTEOTOMY FOCUS AND REPLACEMENT OF THE SYNTHESIS MATERIAL WITH FRACTURE. DURING THE PROCEDURE, INTENSE METALLOSIS + FRACTURE OF THE PLATE 1/3 TUBE WAS OBSERVED IN A TITANIUM OF 5 HOLES, THROUGH ITS 3 HOLE IN THE PROXIMAL FRAGMENT OF THE MENTIONED PATIENT'S ULNA. IN THE FOLLOW-UP OF THE PATIENT, SHE DID NOT REPORT ANY NEW TRAUMAS OR MAJOR PHYSICAL EFFORT THAT WOULD JUSTIFY SUCH AN EVENT, SINCE THE PATIENT IS AWAITING EVALUATION AND DIAGNOSIS OF THE SYNTHESIS MATERIAL IN QUESTION."

  Patient problems: Failure of Implant; Metal Related Pathology

  MAUDE report 10667378 ↗
• InjuryAug 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT'S LEFT RADIUS WAS REVISED 1 MONTH POST-OP DUE TO A BENT PLATE. THE BENT RADIUS PLATE AND AN ULNAR PLATE WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE ULNAR PLATE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10379524 ↗
• InjuryAug 5, 2020Fracture; Fracture

  PATIENT STATED SHE HAD A STRYKER EXTERNAL FIXATOR IMPLANTED ON LEFT ANKLE ON (B)(6) 2019 TO MOVE ANKLE OVER 30 DEGREES. ON (B)(6) 2019 THEY REMOVED THE EXTERNAL FIXATOR AND IMPLANTED AN INTERNAL FIXATOR, PLATES AND SCREWS. PATIENT WAS CLEARED FOR PHYSICAL THERAPY IN DECEMBER AND CONTINUE PT FOR TWO MONTHS. ON (B)(6) 2020 SHE WAS WALKING AROUND HER HOUSE AND HEARD A POP. PATIENT WENT TO THE URGENT CARE AND THEY TOOK X-RAYS WHICH SHOWED A BROKEN PLATE, LOOSE SCREWS AND HER ANKLE WENT BACK TO 45 DEGREES. PATIENT IS EXPERIENCING PAIN, WHICH HAS GOTTEN WORSE THESE PAST TWO WEEKS.

  Patient problems: Deformity/ Disfigurement; Injury; Pain

  MAUDE report 10368126 ↗