BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TL PEDICLE SCREW, DIA 6.5 X 45MM

    MDR report key: 6570798 · Received May 16, 2017

    Report

    Report Number
    3003853072-2017-00051
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    April 11, 2017
    Report Date
    September 7, 2017
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PNA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER PHOTOGRAPHS WERE PROVIDED AND USED FOR THE EVALUATION. THE THREADED SHAFT HAD FRACTURED; THE COMPLAINT IS CONFIRMED. THE FRACTURED SCREWS WERE FOUND FOUR YEARS AFTER BEING IMPLANTED AND BONY FUSION WAS ACHIEVED AT THE SITE. IT CANNOT BE CONCLUDED THAT THE SCREWS BROKE BEFORE THE FUSION OCCURRED. A REVIEW OF THE DEVICE LABELING SHOWS THAT THIS IS A KNOWN RISK OF THE PROCEDURE SINCE REPEATED STRESSES ON THE DEVICES OVER TIME CAN LEAD TO DEVICE FRACTURE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED FOR USE IN OR MARKETED WITHIN THE US. IT IS A SIMILAR PRODUCT TO THOSE CLEARED BY K111301 UNDER PRODUCT CODE NKB. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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. REFERENCE REPORTS 3003853072-2017-00049 THRU 3003853072-2017-00051.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PEDICLE SCREWS FRACTURED POST-OPERATIVELY. THE SCREWS WERE INSTALLED FOR APPROXIMATELY THREE YEARS PRIOR TO THE BREAKAGE. A REVISION SURGERY WAS PERFORMED TO ADDRESS THE BROKEN SCREWS. THERE WERE NO OTHER REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351828 TL PEDICLE SCREW, DIA 6.5 X 45MM JAVA TOP LOADING NKB ZIMMER SPINE NA H17658J

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R