BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 1033394 · Received April 22, 2008

    Report

    Report Number
    MW5006372
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 22, 2008
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF POST OPERATIVE HEALING FOLLOWING A 1ST METATARSOPHALANGEAL JOINT FUSION, THE IMPALNTED HARDWARE BECAME LOOSE BUT NONPAINFUL. DRAINAGE DEVELOPED, ANTIBIOTIC TREATMENT FOLLOWED AND THEN A RETURN TO THE OR FOR REMOVAL OF THE IMPLANTED HARDWARE AND DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES PLATE HRS SYNTHES PLATE EPIPHYSIS
    2 SYNTHES SCREW, CORTEX SELFTAPPING 2.7 X 12MM HWC SYNTHES
    3 SYNTHES SCREW, CORTEX SELFTAPPING 2.7 X 12MM HWC SYNTHES
    4 SYNTHES SCREW, SELFTAPPING 2.7 X 14MM HWC SYNTHES
    5 SYNTHES SCREW, CORTEX SELFTAPPING 2.7 X 14MM HWC SYNTHES
    6 SYNTHES SCREW, CORTEX SELFTAPPING 2.7 X 16MM HWC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability