BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C DIAM.3.5MM SELF TAPPING 10MM

    MDR report key: 2991867 · Received March 6, 2013

    Report

    Report Number
    3005525032-2013-00017
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVE
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ANCHOR C SCREW WAS REPORTED HAVING ITS CLIP DISLODGED. THE SCREW WAS LOST AND THEREFORE WON¿T BE RETURNED. BATCH NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IT IS IMPOSSIBLE TO DETERMINE UNDER WHICH CONDITION IT HAS DISLODGED. SURGICAL TECHNIQUE WARNS ABOUT EXCESSIVE PIVOTING OR ANGULATION OF THE DRILLING GUIDE THAT CAN CAUSE DAMAGES AS WELL AS EXCESSIVE PIVOTING OR ANGULATION ON THE SCREWDRIVER THAT CAN CAUSE DAMAGE TO THE SCREWDRIVER AND/OR SCREW. WHILE IT IS POSSIBLE THAT THE REPORTED EVENT IS THE RESULT OF THE CONDITION OF USE, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN. DEVICE NOT RETURNED. THE SCREW IS REPORTED LOST AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ANCHOR C CASE. TECHNIQUE WAS FOLLOWED AND GUIDE WAS USED. AFTER PLACING FIRST SCREW THE PA NOTICED THE LOCKING CLIP ON SCREW HAD DISLODGED COMPLETELY FROM SCREW. REMOVED SCREW AND CONFIRMED CLIP WAS NOT ON SCREW. REPLACED WITH A RESCUE 4.0 SCREW AND WENT IN CORRECTLY. SECOND SCREW WAS DRILLED TO A 10MM. USED A 10MM SELF TAPPING SCREW AND COULD NOT GET SCREW TO ADVANCE ALL THE WAY. SURGEON WAS WORRIED IT WAS AN ISSUE WITH THE LOCKING CLIP SO REPLACED WITH ANOTHER 10MM SELF TAPPING SCREW AND IT ADVANCED ALL THE WAY AND WAS LOCKED IN PLACE. WASTED 2 SCREWS ARE BEING RETURNED. 10 MINUTE DELAY IN SURGERY"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ANCHOR C CASE. TECHNIQUE WAS FOLLOWED AND GUIDE WAS USED. AFTER PLACING FIRST SCREW, THE PA NOTICED THE LOCKING CLIP ON SCREW HAD DISLODGED COMPLETELY FROM SCREW. REMOVED SCREW AND CONFIRMED CLIP WAS NOT ON SCREW. REPLACED WITH A RESCUE 4.0 SCREW AND WENT IN CORRECTLY. SECOND SCREW WAS DRILLED TO A 10MM. USED A 10MM SELF TAPPING SCREW AND COULD NOT GET SCREW TO ADVANCE ALL THE WAY. SURGEON WAS WORRIED IT WAS AN ISSUE WITH THE LOCKING CLIP SO REPLACED WITH ANOTHER 10MM SELF TAPPING SCREW AND IT ADVANCED ALL THE WAY AND WAS LOCKED IN PLACE. WASTED 2 SCREWS ARE BEING RETURNED. 10 MINUTE DELAY IN SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96311 ANCHOR C DIAM.3.5MM SELF TAPPING 10MM SCREW IMPLANT OVE STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR