BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVSPINE-EXP-HEADSCR 4 SELF-DRILL L14

    MDR report key: 4152090 · Received October 8, 2014

    Report

    Report Number
    8030965-2014-01601
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    December 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INSPECTION OUTCOME REVEALED THAT THE SCREW IS 16 MM INSTEAD OF 14 MM. THE COMPLAINED SCREW IS ANODIZED GOLD, THIS INDICATES THAT THE SCREW FOLLOWED THE FINISH PROCESS OF THE CERVICAL SPINE EXPANSION HEAD SCREW AND THAT THE MIX UP OCCURRED BEFORE THE ANODIZATION PROCESS. PLACEHOLDER.

    Description of Event or Problem · 1

    DOCTOR FOUND THE LENGTH OF SCREW WAS NOT CORRECT. THE SURGERY WAS NOT DELAYED. ANOTHER SCREW WAS USED AND THE PATIENT WAS NOT IMPACTED. NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632867 CERVSPINE-EXP-HEADSCR 4 SELF-DRILL L14 KWQ SYNTHES GMBH 8395713

    Patients

    Seq Age Sex Outcome Treatment
    1