BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPLANAR SCREW (TI-6AL-4V)

    MDR report key: 3960931 · Received July 28, 2014

    Report

    Report Number
    2027467-2014-00021
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K100685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT EVALUATION CAN BE CONDUCTED. THE SPLAYED/BENT UNIPLANAR SCREW REMAINS SECURED WITHIN THE PATIENTS L1 VERTEBRAL BODY. THE IDENTIFYING PART AND LOT NUMBERS HAVE NOT BEEN PROVIDED. BASED ON THE SUPPLIED PHOTO AND WHAT WAS DESCRIBED IN THE REPORT, IT APPEARS THE AXIAL REDUCER MAY NOT HAVE BEEN COMPLETELY ATTACHED AND WHEN THE FORCES WERE PLACED ON THE SCREW DURING THE DE-ROTATION MANEUVER. IF THE INSTRUMENT (AXIAL REDUCER) IS NOT ATTACHED APPROPRIATELY WITH GOOD ALIGNMENT THE SETSCREW MAY BE SLIGHTLY MISALIGNED WHICH COULD POTENTIALLY LEAD TO A CROSS THREADING OF THE SETSCREW. THE ZODIAC SPINAL FIXATION SYSTEM IS INTENDED FOR USE AS A POSTERIOR SPINAL FIXATION DEVICE TO AID IN THE SURGICAL CORRECTION OF VARIOUS SPINAL DEFORMITIES AND PATHOLOGIES OF THE SPINE. IT IS INTENDED TO PROVIDE STABILIZATION DURING THE DEVELOPMENT OF FUSION UTILIZING A BONE GRAFT. SPECIFIC INDICATIONS FOR THE ZODIAC SYSTEM ARE DEPENDENT IN PART ON THE CONFIGURATION OF THE ASSEMBLED DEVICE AND THE METHOD OF ATTACHMENT TO THE SPINE.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (B)(6) REPORTED AN INCIDENT INVOLVING A ZODIAC UNIPLANAR SCREW. THE EVENT OCCURRED DURING A DEFORMITY (IDIOPATHIC SCOLIOSIS) CASE ON (B)(6) 2014. DURING THE FINAL TIGHTENING PROCESS, THE HEAD/TULIP OF THE ZODIAC UNIPLANAR SCREW LOCATED AT THE L1 BENT AND CRACKED PREVENTING TORQUING OF THE SET SCREW. THE SPLAYED HEAD/TULIP DID NOT DETACH FROM THE BODY OF THE UNIPLANAR SCREW, IT REMAINS POSITIONED AT THE L1 ENTRAPPED BENEATH THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437604 UNIPLANAR SCREW (TI-6AL-4V) KWP, MNI, MNH KWP ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other