BEUDAMED
    FDA Adverse Event Other Summary report: N

    SBI PIP IMPLANT

    MDR report key: 951566 · Received April 13, 2007

    Report

    Report Number
    3003640913-2007-00001
    Event Type
    Other
    Date Received
    April 13, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 12, 2007
    Manufacturer
    SBI
    Product Code
    MPK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL IMPLANTS WERE LONG TERM, BELIEVED TO BE 1.5 TO 2.5 YRS. NO DEVICE FAILURE REPORTED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT 10 OUT OF 42 PTS HE WAS FOLLOWING REQUIRED REVISION SURGERY DUE TO THE LOOSENING OF THE IMPLANT. OUT OF THE 10 REVISIONS, 5 HAD THE IMPLANT REPLACED, 3 HAD A SILICONE IMPLANT REPLACEMENT AND 2 HAD THE JOINT FUSED (ARTHRODESIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SBI PIP IMPLANT PROXIMAL INTERPHALAGEAL IMPLANT MPK SBI SR PIP, -1-2-3-4-5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other