BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4 X 9.0MM SELF DRILLING SCREW

    MDR report key: 15849498 · Received November 22, 2022

    Report

    Report Number
    3012447612-2022-00272
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Report Date
    February 16, 2023
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K100805
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION WAS ENTERED ERRONEOUSLY; THESE FIELDS SHOULD BE BLANK SINCE THERE WAS NO PATIENT INVOLVEMENT. PRODUCT CODE: NQW. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT NOT RETURNED AND PHOTOS NOT PROVIDED. COMPLAINT UNABLE TO BE CONFIRMED. DHR REVIEW: DHR REVIEW UNABLE TO BE COMPLETED AS LOT INFORMATION IS NOT KNOWN. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE DISTRIBUTOR NOT APPROPRIATELY INSPECTING THE PRODUCT AFTER LABELING AND PRIOR TO SHIPMENT. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS FOUND THAT A GALLERY 2.8X9MM (14-523102) SCREW WAS IN THE BAG THAT WAS LABELED AS GALLERY 2.4X9MM (14-523097). THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS FOUND THAT A GALLERY 2.8X9MM (14-523102) SCREW WAS IN THE BAG THAT WAS LABELED AS GALLERY 2.4X9MM (14-523097). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796804 2.4 X 9.0MM SELF DRILLING SCREW GALLERY LAMINOPLASTY FIXATION SYSTEM KWQ ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown