BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, SHO

    MDR report key: 1220545 · Received November 3, 2008

    Report

    Report Number
    8010177-2008-00080
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    September 26, 2008
    Report Date
    November 3, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGERY WITH THE MATRIX SMART LOCK PLATE AT A DIFFERENT HOSPITAL (DATE OF SURGERY UNK). AFTER SURGERY, THE PATIENT VISITED THIS HOSPITAL SINCE HE HAD PAIN IN HIS DISTAL RADIUS. THE SURGEON FOUND THROUGH THE X-RAY THAT THE LOCKING PLATE WAS BROKEN AND THE PIECE OF THE FRACTURED BONE TRANSFERRED AND THE BONE IS FIXED IN INCORRECT ALIGNMENT AS A RESULT. ON 2008 (B) (6), THE REVISION SURGERY WAS PERFORMED. THE SURGEON REMOVED THE LOCKING PLATE AND PERFORMED THE CARPAL TUNNEL RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, SHO IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG J1E00F1671

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention