BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 3250050 · Received July 26, 2013

    Report

    Report Number
    2520274-2013-04416
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    . DEVICE USED FOR TREATMENT NOT DIAGNOSIS. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR CERVICAL FIXATION ON UNKNOWN DATE IN SEPTEMBER, 2012. ON AN UNKNOWN DATE, THE SURGEON DETERMINED THAT ONE OR MORE OF THE POSTERIOR SCREWS HAD PULLED OUT OF THE CONSTRUCT, AND ADJACENT LEVEL DISEASE WAS NOTED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR POSTERIOR REVISION TO REMOVE AND REIMPLANT HARDWARE TO EXTEND THE POSTERIOR CONSTRUCT, AND SIMULTANEOUSLY WAS SCHEDULED FOR A MULTILEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) USING TWO ZERO-P IMPLANTS AND 3 ALLOGRAFT SPACERS WITH A 3-LEVEL CERVICAL PLATE. THE POSTERIOR CONSTRUCT WAS REMOVED, AND THE SURGEON DISCOVERED AN INFECTION WAS PRESENT. IT WAS DECIDED NOT TO REINSTRUMENT THE POSTERIOR ASPECT AT THIS TIME. THE PATIENT WAS THEN TURNED TO PROCEED WITH THE ACDF. THE SUPERIOR ZERO-P IMPLANT, SCREWS AND THE 3 ALLOGRAFT SPACERS WERE ALL PLACED WITH NO PROBLEM, AND THE 3 LEVEL PLATE HAD NOT YET BEEN AFFIXED. AS THE SURGEON ATTEMPTED TO PLACE THE LOWER (INFERIOR) ZERO-P IMPLANT, ONE OF THE SCREWS WOULD NOT ADVANCE. THE SURGEON TRIED A SECOND SCREW, AND IT ALSO WOULD NOT INSERT. UPON CLOSER INSPECTION, THE SURGEON FOUND THE IMPLANT PORTION OF THE ZERO-P WAS BROKEN. THE SURGEON REMOVED THE ZERO-P DEVICE, AND 5 SCREWS; PLACED A 4TH ALLOGRAFT SPACER, AND PLATED WITH A 4-LEVEL PLATE INSTEAD OF THE INTENDED 3-LEVEL PLATE. IT WAS REPORTED THAT SURGERY WAS DELAYED 20-30 MINUTES, THE PROCEDURE WAS THEN COMPLETED. THIS IS REPORT 3 OF 6 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350782 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1