BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQ TRANSVERSE CONN. LARGE

    MDR report key: 5457209 · Received February 24, 2016

    Report

    Report Number
    0002184052-2016-00008
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    July 27, 2015
    Report Date
    February 23, 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 WAS LUMBAR 5-SACRAL 1 POSTERIOR DECOMPRESSION, INTERBODY FUSION AND INSTRUMENTATION. IT WAS REPORTED THAT A SCREW HAD FRACTURED ON (B)(6) 2015. ALL ZIMMER BIOMET HARDWARE WAS REMOVED AND RE-INSTRUMENTED WITH ADDITION L4-5 SEGMENT. STABLE CONDITION AT DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114332 SEQ TRANSVERSE CONN. LARGE CROSSLINK NKB ZIMMER SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R