BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOU ANTERIOR LUMBAR PLATE SYSTEM

    MDR report key: 6301654 · Received February 3, 2017

    Report

    Report Number
    3006494201-2017-00003
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    December 14, 2016
    Report Date
    February 3, 2017
    Manufacturer
    CORELINK, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K121791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR IDENTIFIED THAT THERE WAS NO MALFUNCTION WITH THE ZOU DRIVER SHAFT AND THE PART FUNCTIONED AS INTENDED. THIS OCCURENCE SEEMS TO BE ATTRIBUTED TO MISUSE OF THE DRIVER SHAFT WITHOUT THE DRIVER RETAINING SLEEVE. NO LOT# WAS PROVIDED FOR THE INSTRUMENT BEING UTILIZED AT THE TIME OF OCCURENCE AND NO RETURN OF THE DEVICE WAS MADE TO THE MANUFACTURER FOR EVALUATION. USER ERROR.

    Description of Event or Problem · 1

    SURGEON WAS UTILIZING ZOU ANTERIOR LUMBAR SCREW DRIVER SHAFT DURING INSERTION OF SCREWS IN A LUMBAR PLATE IMPLANTATION. THE DRIVER SHAFT ALLEGEDLY SLIPPED OUT OF THE MATING SCREW HEX AND PUNCTURED ONE OF THE "GREAT VESSELS". IT WAS IDENTIFIED THAT THE DRIVER SHAFT WAS NOT BEING UTILIZED IN CONJUNCTION WITH THE ANTERIOR LUMBAR DRIVER SLEEVE AS INSTRUCTED IN THE SURGICAL TECHNIQUE MANUAL, WHICH RETAINS THE DRIVER SHAFT AND HEAD OF THE MATING SCREW DURING INSERTION. FURTHER INFORMATION WAS PROVIDED THAT IDENTIFIED THE PATIENT RECOVERED IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84568 ZOU ANTERIOR LUMBAR PLATE SYSTEM SPINAL FIXATION DEVICE KWQ CORELINK, LLC 2010-101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other