BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK HANDLE ROD HOLDER

    MDR report key: 1190746 · Received October 6, 2008

    Report

    Report Number
    1649384-2008-00511
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW INDICATE THE PART MET SPECIFICATION. THE VISUAL EXAMINATION OF THE RETURNED PART INDICATES A MISSING SPRING AND LATCH COMPONENTS. THE REPORT INDICATES THE LATCH BROKE DURING USE. THE REPORT INDICATES THE CASE WAS A DIFFICULT GRADE 3 SPONDYLOLITHESIS. THE LIKELY CAUSE FOR THE BROKEN LATCH ON THE INSTRUMENT IS DUE TO EXCESSIVE ROD MANIPULATION FORCE APPLIED TO CORRECT THE DEFORMITY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT DURING AN L-5 GRADE 3 SPONDYLISTHESIS SURGERY IN 2008, THE LATCH ON THE BACK OF THE SLEEK HANDLE ROD HOLDER BROKE OFF, THE SCREW CAME OFF, AND WAS LOST. THE EXACT TIMING OF THE MALFUNCTION IS UNK. THE SALES REPRESENTATIVE DID NOT REPORT ANY INTERVENTION REGARDING THIS MALFUNCTION. THERE WAS NO SURGICAL DELAY AND NO REPORT OF HARM TO THE PT. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK HANDLE ROD HOLDER PATHFINDER LXH ABBOTT SPINE 33XZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK