BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAR RADIUS FRACTURE PLATE, LOCKING, SMALL, LONG

    MDR report key: 2033730 · Received February 11, 2011

    Report

    Report Number
    8010177-2011-00045
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT BROKE BOTH SIDES OF THE DISTAL RADIUS AND HAD A FEMORAL MEDICAL NECK FRACTURE. LONG PLATE WAS USED FOR THE SHAFT OF THE LEFT RADIUS WITH NO BONE GRAFT. SHORT PLATE WAS USED FOR THE INTRA-ARTICULAR FRACTURE OF RIGHT RADIUS ON (B)(6) 2010. SCHIENENVERBAND WAS USED ON THE SAME DAY. ON (B)(6) 2010, FEMORAL HEAD REPLACEMENT HAD TO BE DONE. FROM (B)(6) 2011, THE PATIENT STARTED TO BE IN A SEATED POSITION IN A WHEELCHAIR, AND THERE WERE NO PROBLEMS APPARENT FROM THE X-RAY FILM THEN. ON (B)(6) 2011, IT WAS FOUND THAT THE LONG PLATE ON LEFT RADIUS WAS BENT ON X-RAY FILM. IT WAS POSSIBLE THAT THOUGH THE PATIENT USED HANDS DURING SEATING ON THE WHEELCHAIR, SCHIENENVERBAND HAD BEEN KEPT ROLLING AFTER ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAR RADIUS FRACTURE PLATE, LOCKING, SMALL, LONG IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA KA600F1726

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR