BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQ TRANSVERSE CONN. LARGE

    MDR report key: 5457670 · Received February 24, 2016

    Report

    Report Number
    0002184052-2016-00009
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    June 15, 2015
    Report Date
    January 28, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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.

    Description of Event or Problem · 1

    THE ORIGINAL SURGERY LUMBAR 2-3-4 PLIF WAS PERFORMED. FACET INCOMPETENCY AND INSTABILITY AT LUMBAR 2-3, 3-4. ON (B)(6) 2015 THE PATIENT COMPLAINED OF AUDIBLE CREAKING IN HIS LOWER BACK. A REVISION TOOK PLACE ON (B)(6) 2015 TO CORRECT A LOOSE BLACK AND SCREW. ALL ZIMMERBIOMET PARTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114683 SEQ TRANSVERSE CONN. LARGE CROSSLINK NKB ZIMMER SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R