BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM

    MDR report key: 4861564 · Received June 23, 2015

    Report

    Report Number
    0009617544-2015-00284
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 28, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K040261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: MANUFACTURING RECORDS FOR THIS PRODUCT WERE REVIEWED AND NO ANOMALIES WERE FOUND. NO MANUFACTURING ANOMALIES AND IT APPEARS THAT THE TECHNIQUE WAS FOLLOWED. CONCLUSION: A ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY FOUND THE LOCKING RINGS WERE BROKEN AND DESTROY THE NAIL DURING SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY FOUND THE LOCKING RINGS WERE BROKEN AND DESTROY THE NAIL DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405614 REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ STRYKER SPINE-FRANCE 143216

    Patients

    Seq Age Sex Outcome Treatment
    1