BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW INSERTER

    MDR report key: 2053408 · Received March 1, 2011

    Report

    Report Number
    1530901-2011-00011
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 1, 2011
    Manufacturer
    INTEGRA, AKRON
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    DURING ANTERIOR CERVICAL DISCECTOMY SURGERY (DISC SURGERY ON THE CERVICAL SPINE),THE SURGEON WAS PERFORMING THE FINAL TIGHTENING AND TORQUING OF A SCREW USING THE MANTA RAY SCREW INSERTER WHEN THE INSTRUMENT STRIPPED OUT. A SECOND MANTA RAY SCREW INSERTER ((B)(4) LOT # W11643) WAS AVAILABLE AND USED AND ALSO STRIPPED OUT. A THIRD DEVICE ((B)(4)- LOT #W11017) MANTA RAY INSERTER WITH FORCED TIP WAS PROVIDED AND ALSO STRIPPED. THE REPORTER STATED THAT THE SURGEON COULD NOT DRIVE DOWN THE SCREW AS FAR AS PREFERRED DESPITE USING "A TON OF TORQUE" BUT WAS ABLE TO GET PAST THE LOCK AND FINALLY SEATED THE SCREW DOWN. A F/U X-RAY WAS DONE AFTER SEATING THE SCREW DOWN AND SHOWED SATISFACTORY PLACEMENT OF THE SCREW. SURGERY WAS COMPLETED AND THERE WAS NO ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW INSERTER MANTARAY KWQ INTEGRA, AKRON W8609

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR