BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN IMPLANT CLOSURE TOP

    MDR report key: 6173385 · Received December 14, 2016

    Report

    Report Number
    3004485144-2016-00380
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Report Date
    June 27, 2017
    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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE RETURNED CLOSURE TOPS WERE EVALUATED. THE THREADS WERE FOUND TO HAVE SHEARED OFF IN A MANNER CONSISTENT WITH CROSS-THREADING. THE COMPLAINT IS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    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 SEVEN FOR THIS EVENT. REFERENCE REPORTS 3004485144-2016-00369, 3004485144-2016-00374, 3004485144-2016-00375, AND 3004485144-2016-00378 THRU 3004485144-2016-00381.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THREADING A CLOSURE TOP INTO A REDUCTION SLEEVE DURING A PROCEDURE, THE CLOSURE TOP CROSS-THREADED AT THE TRANSITION BETWEEN THE SLEEVE AND THE PEDICLE SCREW TULIP. IT WAS REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823907 OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE N/A 86KW

    Patients

    Seq Age Sex Outcome Treatment
    1