BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 5931168 · Received September 6, 2016

    Report

    Report Number
    3005525032-2016-00104
    Event Type
    Malfunction
    Date Received
    September 6, 2016
    Date of Event
    August 10, 2016
    Report Date
    August 10, 2016
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    UDI-DI
    04546540560193
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT. THE HOSPITAL WOULD NOT RETURN THE PRODUCTS FOR EVALUATION, SO VISUAL AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. LOT NUMBERS COULD NOT BE PROVIDED TO COMPLETE MANUFACTURING AND COMPLAINT HISTORY REVIEWS. THERE IS NOT ENOUGH INFORMATION TO DEFINITIVELY CONCLUDE A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW SPLAYED OPEN DURING FINAL TIGHTENING ON BOTH SCREWS IMPLANTED DURING THE CASE. THE SURGICAL DELAY WAS 3 MINUTES. THE SURGEON PLACED NEW BLOCKERS IN AND LEFT THE SCREWS IN PLACE. I DO NOT HAVE THE PRODUCTS TO SEND BACK TO CORPORATE BECAUSE THE HOSPITAL WOULD NOT LET ME HAVE THEM. I DO NOT KNOW THE LOT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW SPLAYED OPEN DURING FINAL TIGHTENING ON BOTH SCREWS IMPLANTED DURING THE CASE. THE SURGICAL DELAY WAS 3 MINUTES. THE SURGEON PLACED NEW BLOCKERS IN AND LEFT THE SCREWS IN PLACE. I DO NOT HAVE THE PRODUCTS TO SEND BACK TO CORPORATE BECAUSE THE HOSPITAL WOULD NOT LET ME HAVE THEM. I DO NOT KNOW THE LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582746 XIA 3 TITANIUM BLOCKER PEDICLE SCREW SPINAL SYSTEM. MNH STRYKER SPINE-SWITZERLAND UNKNOWN 04546540560193

    Patients

    Seq Age Sex Outcome Treatment
    1