BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN IMPLANT CLOSURE TOP

    MDR report key: 6171939 · Received December 13, 2016

    Report

    Report Number
    3004485144-2016-00373
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS IS REPORT SIX OF SIX FOR THIS EVENT. REFERENCE REPORTS 3004485144-2016-00367 THRU 3004485144-2016-00368 AND 3004485144-2016-003070 THRU 3004485144-2016-00373.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLOSURE TOPS WERE STRIPPING WITHIN THE SHORT EXTENSION SLEEVES. THE CLOSURE TOPS WERE REPLACED AND THE FINAL TIGHTENING WAS PERFORMED WITH THE COUNTER TORQUE INSTEAD OF THE SLEEVES. THERE WAS NO PATIENT INJURY REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821368 OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1