BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY SCREW, UNKNOWN SIZE OR TYPE

    MDR report key: 9772323 · Received February 28, 2020

    Report

    Report Number
    3012447612-2020-00169
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    January 28, 2020
    Report Date
    September 17, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: METHOD, RESULTS AND CONCLUSION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION FOR AN UNKNOWN REASON TO REMOVE AND REPLACE VITALITY HARDWARE. THERE WERE NO REPORTED ADDITIONAL PATIENT IMPACTS. THIS IS REPORT NINE OF TEN.

    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. REFERENCE REPORTS 3012447612-2020-00161 TO 3012447612-2020-00170.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION FOR AN UNKNOWN REASON TO REMOVE AND REPLACE VITALITY HARDWARE. THERE WERE NO REPORTED ADDITIONAL PATIENT IMPACTS. THIS IS REPORT NINE OF TEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233009 VITALITY SCREW, UNKNOWN SIZE OR TYPE VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R