BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQ TRANSVERSE CONN. LARGE

    MDR report key: 5457295 · Received February 24, 2016

    Report

    Report Number
    0002184052-2016-00010
    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
    Product Problem
    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 FOR STENOSIS AT LUMBAR 4-5, LUMBAR 5-SACRAL 1 STENOSIS WITH INSTABILITY AL L4-5 WITH NEUROGENIC CLAUDICATION. LUMBAR 4-5, LUMBAR 5-SACRAL 1 POSTERIOR DECOMPRESSION , INTERBODY FUSION AND INSTRUMENTATION. THE REVISION WAS TO EXPLANT AND REPLACE ALL ZIMMER BIOMET HARDWARE WITH ADDITIONAL LEVEL, LUMBAR 3-4, DUE TO JUNCTIONAL INSTABILITY. LUMBAR 3-4, 4-5, LUMBAR 5-SCARAL 1 ALIF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114389 SEQ TRANSVERSE CONN. LARGE CROSS LINK NKB ZIMMER SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R