BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8782247 · Received July 11, 2019

    Report

    Report Number
    1030489-2019-00744
    Event Type
    Injury
    Date Received
    July 11, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K180700 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE TYPE OF PROCEDURE: BALLOON KYPHOPLASTY LEVEL IMPLANTED: L2 IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE IMPLANTED CEMENT AT L2 MIGRATED OUT OF L2 VERTEBRA. DUE TO THIS EVENT, PATIENT EXPERIENCED RECURRENCE OF LOW BACK PAIN. IT WAS EARLIER PLANNED TO PERFORM FIXATION SURGERY ON (B)(6) 2019 DUE TO THIS EVENT; BUT THE RE-OPERATION IS NOW INDEFINITELY POSTPONED AS THE PATIENT'S GENERAL CONDITION IS BAD. IT IS JUDGED THAT THERE IS COMPLETELY NO RELEVANCE BETWEEN THE BAD GENERAL CONDITION OF THE PATIENT AND THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573360 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL70095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other