BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY SCREW, UNKNOWN SIZE OR TYPE

    MDR report key: 9387363 · Received November 27, 2019

    Report

    Report Number
    3012447612-2019-00498
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    August 16, 2018
    Report Date
    August 5, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: RESULTS AND CONCLUSIONS. THE SCREW WAS NOT RETURNED, AND NO X-RAYS OR PHOTOS WERE PROVIDED SO AN EVALUATION WAS UNABLE TO BE PERFORMED. THEREFORE, NO RESULTS ARE AVAILABLE AND THE CAUSE CANNOT BE DETERMINED. THE DHR WAS UNABLE TO BE REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. THE DEVICE'S LABELING WAS REVIEWED AND IDENTIFIES IMPLANT FRACTURE AND SUBSEQUENT SURGERIES AS POSSIBLE ADVERSE EFFECTS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE TWO BROKEN SCREWS. NO ADDITIONAL SURGICAL INFORMATION OR ADDITIONAL PATIENT IMPACTS WERE PROVIDED. THIS IS REPORT TWO OF TWO.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K171907 OR K150896. 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. REFERENCE REPORT 3012447612-2019-00497. [MW5090372].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE TWO BROKEN SCREWS. NO ADDITIONAL SURGICAL INFORMATION OR ADDITIONAL PATIENT IMPACTS WERE PROVIDED. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175878 VITALITY SCREW, UNKNOWN SIZE OR TYPE VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R