BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE CEMENT

    MDR report key: 2940351 · Received February 3, 2013

    Report

    Report Number
    2953769-2013-00016
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    May 28, 2012
    Report Date
    January 16, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). CEMENT LEAK. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ARTICLE OF RETROSPECTIVE STUDY OF 25 PATIENTS (10 MALE AND 15 FEMALE) OVER THE AGE OF (B)(6) WHO UNDERWENT BALLOON KYPHOPLASTY FOR TRAUMATIC COMPRESSION FRACTURE. PATIENTS WERE EVALUATED TO DETERMINE THE SUCCESS OF THE TECHNIQUE IN TERMS OF RESTORATION OF SPINAL STABILIZATION. MEAN PATIENT AGE WAS (B)(6). AVERAGE HOSPITAL STAY WAS 3 DAYS AND THE AVERAGE DURATION OF FOLLOW UP WAS 2 YEARS. COMPARED WITH PREOPERATIVE MEASUREMENTS, THE RESTORATION RATIOS WAS 43% IN THE ANTERIOR CORONAL PLANE, 35% IN THE MID-CORONAL PLANE, AND 43% IN THE POSTERIOR CORONAL PLANE. POSTERIOR FUSION WAS PERFORMED BY DECORTICATION OF THE FACET JOINTS. ASYMPTOMATIC CEMENT LEAKAGE WAS NOTED IN 1 PATIENT. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45738 BONE CEMENT ARTHROSCOPE HRX KYPHON NEUCHATEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1