BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE TOP

    MDR report key: 11946631 · Received June 7, 2021

    Report

    Report Number
    3012447612-2021-00196
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    April 26, 2021
    Report Date
    September 1, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K150896
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, TYPE OF INVESTIGATIONS, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS AND X-RAYS WERE NOT PROVIDED, SO A DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN ADVERSE EVENTS, PATIENT FACTORS OR OPERATIONAL FACTORS. DHR REVIEW: LOT NUMBERS ARE NOT KNOWN, SO DHR REVIEW COULD NOT BE PERFORMED. DEVICE USAGE: 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. 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 THAT A PATIENT UNDERWENT A SECOND REVISION SURGERY TO TREAT DISCITIS. THE CLOSURE TOP WAS FOUND TO HAVE LOOSENED FROM THE RIGHT S1 SCREW. THE ENTIRE CONSTRUCT HAD TO BE REMOVED DUE TO THE DISCITIS, AND NO NEW IMPLANTS WERE PLACED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SECOND REVISION SURGERY TO TREAT DISCITIS. THE CLOSURE TOP WAS FOUND TO HAVE LOOSENED FROM THE RIGHT S1 SCREW. THE ENTIRE CONSTRUCT HAD TO BE REMOVED DUE TO THE DISCITIS, AND NO NEW IMPLANTS WERE PLACED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    REFERENCE REPORT 3012447612-2021-00195. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SECOND REVISION SURGERY TO TREAT DISCITIS. THE CLOSURE TOP WAS FOUND TO HAVE LOOSENED FROM THE RIGHT S1 SCREW. THE ENTIRE CONSTRUCT HAD TO BE REMOVED DUE TO THE DISCITIS, AND NO NEW IMPLANTS WERE PLACED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844743 CLOSURE TOP VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R