BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 6338524 · Received February 17, 2017

    Report

    Report Number
    2953769-2017-00015
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 24, 2017
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    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 PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# C01A , 510K# K160983 AND (B)(4) IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE UNDERWENT BALLOON KYPHOPLASTY AT TH 11 OR TH12. INTRA OPERATIVELY, DURING BKP SURGERY, THE SURGEON INJECTED CEMENT FROM RIGHT SIDE OF VERTEBRAL BODY FIRST AND WHEN HE WAS INJECTING CEMENT FROM LEFT SIDE, THE CEMENT LEAKED INTO THE SPINAL CANAL. IT WAS REPORTED THAT BALLOON RUPTURED AND CEMENT LEAKED INTO SPINAL CANAL. TRANSIENT PARALYSIS SYMPTOM WAS OBSERVED TO THE PATIENT. THE PATIENT UNDERWENT AN ADDITIONAL DECOMPRESSION PROCEDURE. AS OF (B)(6) 2017, THE PATIENT COULD MOVE HIS (OR HER) LEGS. THE NERVE REACTION HAS STILL REMAINED WEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121304 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other