BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TL PEDICLE SCREW DIA. 6,5 LG 45

    MDR report key: 8773824 · Received July 9, 2019

    Report

    Report Number
    3003853072-2019-00064
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    May 30, 2019
    Report Date
    February 3, 2020
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED IN THE US. IT IS SIMILAR TO PRODUCT CODE NKB CLEARED UNDER K111301. 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 3003853072-2019-00058 THRU 3003853072-2019-00071.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. THERE WAS NO FAILURE MODE DETECTED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS OF 12 SCREWS AND 2 BLOCKERS WERE DAMAGED DURING INSTALLATION IN SURGERY. THEY WERE REMOVED AND REPLACED WITH ALTERNATIVE SCREWS AND BLOCKERS TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS.THIS IS REPORT 7 OF 14 FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS OF 12 SCREWS AND 2 BLOCKERS WERE DAMAGED DURING INSTALLATION IN SURGERY. THEY WERE REMOVED AND REPLACED WITH ALTERNATIVE SCREWS AND BLOCKERS TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT 7 OF 14 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564946 TL PEDICLE SCREW DIA. 6,5 LG 45 JAVA TOP LOADING NKB ZIMMER SPINE NA H26338C

    Patients

    Seq Age Sex Outcome Treatment
    1