BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LUMBAR IMPLANT

    MDR report key: 14074008 · Received April 11, 2022

    Report

    Report Number
    3012447612-2022-00098
    Event Type
    Injury
    Date Received
    April 11, 2022
    Report Date
    August 4, 2022
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MAX
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: UNKNOWN, BUT COULD BE SIMILAR TO MNH, NKB, OR MAX. 510(K): UNKNOWN, BUT COULD BE SIMILAR TO K061441, K150896, OR K110650. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT, PHOTOS OR X-RAYS NOT RETURNED NOR PROVIDED. NO DEVICE EVALUATION WAS ABLE TO BE PERFORMED. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. DHR REVIEW: DHR REVIEW UNABLE TO BE PERFORMED AS LOT NUMBER IS NOT KNOWN. . 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 THAT A PATIENT WAS HAVING PAIN, RESULTING IN DIFFICULTY SLEEPING, WALKING, AND DEPRESSION FOLLOWING A LUMBAR FUSION SURGERY. THE PATIENT IS TAKING PAIN MEDICATIONS. THE IMPLANTED DEVICE IS CURRENTLY UNKNOWN. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE NOT RESPONDED TO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS HAVING PAIN, RESULTING IN DIFFICULTY SLEEPING, WALKING, AND DEPRESSION FOLLOWING A LUMBAR FUSION SURGERY. THE PATIENT IS TAKING PAIN MEDICATIONS. THE IMPLANTED DEVICE IS CURRENTLY UNKNOWN. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION WERE NOT RESPONDED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340328 UNKNOWN LUMBAR IMPLANT NI MAX ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability| O