BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY SCREW, UNKNOWN SIZE OR TYPE

    MDR report key: 9385402 · Received November 27, 2019

    Report

    Report Number
    3012447612-2019-00463
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    June 24, 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 B4, G4, G7, H2, H6: METHODS, RESULTS, AND CONCLUSION CODES. THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. AS SUCH, NO EVALUATION RESULTS ARE AVAILABLE AND NO CONCLUSIONS REGARDING THE CAUSE CAN BE DRAWN. WITHOUT THE RETURNED PRODUCT, THE EVENT IS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A VITALITY SCREW. IT WAS REPORTED THE SCREW WAS FRACTURED. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED OR ADDITIONAL PATIENT IMPACTS REPORTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K150896 OR K171907. 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. [MW5090357.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO REMOVE A VITALITY SCREW. IT WAS REPORTED THE SCREW WAS FRACTURED. THERE WAS NO FURTHER SURGICAL INFORMATION PROVIDED OR ADDITIONAL PATIENT IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181632 VITALITY SCREW, UNKNOWN SIZE OR TYPE VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R