BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TL PEDICLE SCREW DIA. 6,5 LG 50

    MDR report key: 8774012 · Received July 9, 2019

    Report

    Report Number
    3003853072-2019-00067
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    May 30, 2019
    Report Date
    February 4, 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 10 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 10 OF 14 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567128 TL PEDICLE SCREW DIA. 6,5 LG 50 JAVA TOP LOADING NKB ZIMMER SPINE NA H26222D

    Patients

    Seq Age Sex Outcome Treatment
    1