BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 9371351 · Received November 25, 2019

    Report

    Report Number
    1030489-2019-01336
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 25, 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 IT WAS REPORTED THAT THE CEMENT HAD LEAKED OUTSIDE THE PEDICLE AFTER THE OPERATION. THE PATIENT ALLEGED A SLIGHT PAIN ONE DAY AFTER THE OPERATION. IT WAS PLANNED TO PERFORM A REVISION SURGERY TO REMOVE ONLY THE CEMENT THAT CAME OUT AT A LATER DATE. PATIENT ISSUE HAS NOT RESOLVED YET BUT IT IS EXPECTED TO RESOLVE AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166497 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL70110

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention