BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY SCREW, UNKNOWN SIZE OR TYPE

    MDR report key: 9387639 · Received November 27, 2019

    Report

    Report Number
    3012447612-2019-00491
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    August 28, 2019
    Report Date
    August 6, 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 PHOTOS OR X-RAYS WERE PROVIDED, SO AN EVALUATION WAS UNABLE TO BE PERFORMED. THEREFORE, NO FINDINGS ARE AVAILABLE AND THE CAUSE CANNOT BE DETERMINED. THE DHR IS UNABLE TO BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE TWO VITALITY SCREWS. THE SCREWS WERE REPORTED TO BE FRACTURED. THERE WAS NO FURTHER SURGICAL INFORMATION OR PATIENT IMPACTS REPORTED. 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 3012447612-2019-00490- MW5090391

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE TWO VITALITY SCREWS. THE SCREWS WERE REPORTED TO BE FRACTURED. THERE WAS NO FURTHER SURGICAL INFORMATION OR PATIENT IMPACTS REPORTED. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178397 VITALITY SCREW, UNKNOWN SIZE OR TYPE VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R