BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK IMPLANT GENERIC

    MDR report key: 4948736 · Received July 27, 2015

    Report

    Report Number
    2184052-2015-00078
    Event Type
    Injury
    Date Received
    July 27, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. REVIEW OF ALL PROVIDED INFORMATION CONCLUDED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT OR DEFICIENCY AND THIS EVENT IS A KNOWN INHERENT RISK OF THE PROCEDURE. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A BAK IMPLANT AND IS EXPERIENCING POSTOPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485583 BAK IMPLANT GENERIC BAK IMPLANT GENERIC MAX ZIMMER SPINE BAK IMPLANT GENERIC

    Patients

    Seq Age Sex Outcome Treatment
    1