BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS ROD INSERTER

    MDR report key: 2172195 · Received June 15, 2011

    Report

    Report Number
    1649384-2011-00042
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    K100845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED INSTRUMENT CONFIRMED THAT THE SET SCREW HEX WAS DAMAGED. THERE WAS NO REPORT THAT MATERIAL WAS LEFT IN THE PT. THE EXACT CAUSE OF THE STRIPPED SET SCREW COULD NOT BE DETERMINED OR REPLICATED. INTERNAL CORRECTIVE ACTION INVESTIGATION IS EXAMINING FURTHER, BUT NO DETERMINATIONS HAVE BEEN MADE. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE UNLESS ADD'L INFO BECOMES AVAILABLE THAT WOULD AFFECT THE CONTENT OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SET SCREW WAS STRIPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY TO THE CASE OR PT IMPACT. HOWEVER, DEVICE ANALYSIS INDICATES THE SET SCREW HEX WAS STRIPPED AND MATERIAL WAS MISSING FROM THE SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS ROD INSERTER ROD INSERTER NKB ZIMMER SPINE 3564-1 63TJ

    Patients

    Seq Age Sex Outcome Treatment
    1