BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSP BRANTIGAN, SCREW PEDICLE VSP

    MDR report key: 5357803 · Received February 1, 2005

    Report

    Report Number
    5357803
    Event Type
    Malfunction
    Date Received
    February 1, 2005
    Date of Event
    November 10, 2004
    Report Date
    December 28, 2004
    Manufacturer
    DEPUY ACRO MED, INC.
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BROKEN S1 SCREW UNILATERALLY. DISCOMFORT FROM RETAINED SPINAL HARDWARE. (THESE SENT WITH PATIENT; 4 SCREWS AND 2 PLATES). REMOVAL OF VSP NONSEGMENTAL INSTRUMENTATION, PLACEMENT OF OPTIMUM PUTTI ALLOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSP BRANTIGAN, SCREW PEDICLE VSP PEDICLE SCREWS 6.25X40 JDS DEPUY ACRO MED, INC. 2223-2840
    2 VSP BRANTIGAN, SCREW PEDICLE VSP PEDICAL SCREWS 6.25X40 JDS DEPUY ACRO MED, INC.
    3 SP BRANTIGAN, SCREW PEDICLE VSP PEDICAL SCREWS 6355X45 JDS DEPUY ACRO MED, INC.
    4 SP BRANTIGAN, SCREW PEDICLE VSP PEDICAL SCREWS 6355X45 JDS DEPUY ACRO MED, INC.
    5 VSP BRANTIGAN PLATE SPINE VSP III 1/2 S KWQ DEPUY ACRO MED, INC.
    6 VSP BRANTIGAN PLATE SPINE VSP III 1/2 S KWQ DEPUY ACRO MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other