BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 8472682 · Received April 2, 2019

    Report

    Report Number
    1030489-2019-00373
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 2, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # CX01B, 510K #K102397 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-OP DIAGNOSIS: VERTEBRAL FRACTURE (OSTEOPOROSIS) LEVELS IMPLANTED: "1" IT WAS REPORTED THAT INTRA-OP, CEMENT WAS FOUND TO BE TOO FLUID BECAUSE OF WHICH IT WENT THROUGH THE PEDICLES OF THE VERTEBRA. IF THERE IS ANOTHER SPINE SURGERY (SPINAL FUSION) IT WOULD BE VERY COMPLICATED TO GO THROUGH THE PEDICLES INTO THE VERTEBRAL BODY. NO ADDITIONAL TREATMENT WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267460 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 217072862

    Patients

    Seq Age Sex Outcome Treatment
    1