BEUDAMED
    FDA Adverse Event Summary report: N

    VERSAFITCUP CC CANCELLOUS BONE SCREW

    MDR report key: 3832263 · Received May 14, 2014

    Report

    Report Number
    3005180920-2014-00055
    Date Received
    May 14, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC CANCELLOUS BONE SCREW L 35 0 6.5, CODE 01.26.65.35 - LOT 121042 ((B)(4) SCREWS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. VERSAFITCUP CC CANCELLOUS BONE SCREW L 30 0 6.5, CODE 01.26.65.30 - LOT 131304 ((B)(4) SCREWS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED. IT WAS REPORTED THAT THE SURGEON DID NOT PRE-DRILL A HOLE IN THE PT BONE, AS CLEARLY REQUESTED IN THE VERSAFITCUP CC TRIO SURGICAL TECHNIQUE (K103352). ON THE BASIS OF THE DATA COLLECTED, THE EVENT IS HIGHLY LIKELY DUE TO THE SURGICAL MISTAKE ABOVE DESCRIBED.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287919 VERSAFITCUP CC CANCELLOUS BONE SCREW ACETABULAR BONE SCREW L 35 0 6.5 LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1