BEUDAMED
    FDA Adverse Event Other Summary report: N

    SBI SILICONE PIP

    MDR report key: 857527 · Received May 29, 2007

    Report

    Report Number
    3003640913-2007-00003
    Event Type
    Other
    Date Received
    May 29, 2007
    Date of Event
    April 25, 2007
    Report Date
    May 25, 2007
    Manufacturer
    SMALL BONE INNOVATIONS
    Product Code
    MPK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON STATED THE IMPLANT MAY HAVE BEEN DAMAGED BY FORCEPS DURING THE IMPLANT. VISUAL EXAMINATION SHOWS SIGNS OF DAMAGE IN THE AREA OF THE IMPLANT FAILURE.

    Description of Event or Problem · 1

    SILICONE PIP IMPLANT FRACTURED. IMPLANT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SBI SILICONE PIP FINGER JOINT POLYMER CONSTRAINED PROSTH MPK SMALL BONE INNOVATIONS PIP-30 36982002

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other