BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOU ANTERIO LUMBAR SCREW

    MDR report key: 6137078 · Received November 30, 2016

    Report

    Report Number
    3006494201-2016-00001
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 30, 2016
    Manufacturer
    CORELINK, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K121791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART IN QUESTION WAS NOT RETURNED, DISCARDED AT USER FACILITY. SAMPLES WERE REVIEWED FROM THE SAME MANUFACTURE LOT. NO ISSUES COULD BE IDENTIFIED. THIS IS A FIRST TIME OCCURENCE FOR THIS TYPE OF REPORT FROM THIS MANUFACTURER.

    Description of Event or Problem · 1

    DURING A SPINAL SURGERY PERFORMED ON (B)(6) 2016, THE PHYSICIAN CLAIMED THAT WHILE INSERTING A BONE PLATE SCREW INTO A LUMBER BONE PLATE, METAL FRAGMENTS APPEARED TO COME OFF OF THE SCREW AND FALL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED AT THE TIME OF SURGERY AND THE ORIGINAL SCREW WAS DISCARDED. THE USING PHYSICIAN UTILIZED A DIFFERENT SCREW TO FINISH THE PROCEDURE. NO HARM TO PATIENT HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787465 ZOU ANTERIO LUMBAR SCREW SCREW - ANTERIO LUMBAR PLATE KWQ CORELINK, LLC 10155-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other