BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE TOP

    MDR report key: 12741037 · Received November 2, 2021

    Report

    Report Number
    3012447612-2021-00415
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    March 17, 2022
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K150896
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN X-RAY WAS PROVIDED AND USED TO CONFIRM THE CLOSURE TOP BACKED OUT OF ITS MATING SCREW. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED UNKNOWN TRAUMATIC EVENTS, PATIENT FACTORS OR OPERATIONAL IMPACTS. DHR REVIEW THE DHR WAS UNABLE TO BE REVIEWED BECAUSE THE LOT NUMBER IS UNKNOWN. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS A VITALITY CLOSURE TOP THAT BACKED OUT OF A VITAL MIS SCREW POST-OPERATIVELY AT S1. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 REPORT 3012447612-2021-00416.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO ADDRESS A VITALITY CLOSURE TOP THAT BACKED OUT OF A VITAL MIS SCREW POST-OPERATIVELY AT S1. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638654 CLOSURE TOP VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R