BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY

    MDR report key: 2792572 · Received October 16, 2012

    Report

    Report Number
    1030489-2012-01883
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 18, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K042524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PRE-EXISTING DEFECT WAS FOUND AT THE LEVEL OF THE DAMAGE.THE BREAKAGE IS CONSISTENT WITH EXCESSIVE TORQUE APPLIED DURING TIGHTENING OF THE CENTRAL NUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE. IT WAS REPORTED THAT THE SCREW BROKE OFF AFTER TIGHTENING OF THE CROSSLINK. THERE WAS NO PATIENT INJURY REPORTED. THE IMPLANT WAS CHANGED INTRA-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. UPDATE FROM REP: 1 THE BROKEN SCREW WAS NOT THE SET SCREW, BUT THE SCREW IN THE MIDDLE OF THE CONSTRUCT. 2 A NEW CROSS LINK WAS USED SUCCESFULLY DURING THE SURGERY. 3 NO PATIENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALAXY APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0021907W

    Patients

    Seq Age Sex Outcome Treatment
    1