BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

    MDR report key: 9318460 · Received November 13, 2019

    Report

    Report Number
    3004788213-2019-00311
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 15, 2019
    Report Date
    October 19, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    OVD
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI#: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IT IS SIMILAR TO MAX. THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IT IS SIMILAR TO K153495. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, UPON IMPLANTATION THE IMPLANT HOLDER DISASSEMBLED FROM THE IMPLANT DURING IMPACTION. THE IMPLANT WAS REMOVED AND REPLACED WITH AN ALTERNATE TO COMPLETE THE CASE. THERE WAS A SURGICAL DELAY OVER 30 MINUTES IN LENGTH, BUT NO REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114128 ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM ROI-A ALIF CAGE SYSTEM OVD LDR MEDICAL NA 17-167431

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other