BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO AL INSERTER - DISTRACTOR

    MDR report key: 4628853 · Received March 24, 2015

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    Report

    Report Number
    0009617544-2015-00133
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 25, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. DEVICE INSPECTION CONFIRMED DEVICE JAMMING. THIS INDICATES THAT THE JAMMING BETWEEN THE INSERTER GUIDE SHAFT AND THE INSERTER DISTRACTOR SLEEVE IS LIKELY DUE TO THE THREAD MISMATCHING. CONCLUSION: THE PLAUSIBLE ROOT CAUSE IS LIKELY DUE TO THE THREAD MISMATCHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; ISSUE WITH THE INSERTER DISTRACTOR AND THE INSERTER GUIDE - IMPACTION HANDLE WITH ADVANCING THE THREADS, CROSS THREADED. THE PATIENT WAS FLIPPED AND A MIS PLF WAS PERFORMED WITHOUT ANY ISSUES. 30 MINUTE SURGICAL DELAY, HAD TO DISASSEMBLE INSTRUMENT, INSERTED WITHOUT THE SLIDE. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; ISSUE WITH THE INSERTER DISTRACTOR AND THE INSERTER GUIDE ¿ IMPACTION HANDLE WITH ADVANCING THE THREADS, CROSS THREADED. THE PATIENT WAS FLIPPED AND A MIS PLF WAS PERFORMED WITHOUT ANY ISSUES. 30 MINUTE SURGICAL DELAY, HAD TO DISASSEMBLE INSTRUMENT, INSERTED WITHOUT THE SLIDE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196599 AERO AL INSERTER - DISTRACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE 144690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other