BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 3260361 · Received August 1, 2013

    Report

    Report Number
    1030489-2013-03173
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Report Date
    July 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: HIROTSUGU OMI, KEISUKE NAKANO, KEIRYO NAKAHARA, TOMOHIRO LWASAWA, TOSHIMITSU KAWAGISHI. "DOES POSTERIOR VERTEBRAL WALL LNJURY LNFLUENCE THE SAFETY DURING BALLOON KYPHOPLASTY". JOURNAL OF SPINE RESEARCH. VOL. 4, NO. 6; 2013: P 1024-1027. DATE OF EVENT IS UNKNOWN. (B)(6). (B)(4). 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 AN ARTICLE THAT A TOTAL OF 51 PATIENT (56 VERTEBRAE) UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) WITHIN A 7 MONTH PERIOD TO TREAT OSTEOPOROTIC VERTEBRAL FRACTURES (OVF). THE PURPOSE OF THE STUDY WAS TO 'EXAMINE RETROSPECTIVELY WHETHER POSTERIOR VERTEBRAL WALL INJURY WOULD INFLUENCE EMENT LEAKAGE INTO THE SPINAL CANAL." THE AVERAGE AT THE TIME OF OPERATION WAS 73.9 YEARS OLD (RANGE, 52 TO 86 YEARS). THE LEVELS OF OVF WERE : TH7 IN 1 ; TH8 IN 2 ; TH9 IN 2 ; TH10 IN 2 ; TH11 IN 6 ; TH12 IN 9 ; L1 IN 10 ; L2 IN 7 ; L3 IN 6 ; L4 IN 7 ; AND L5 IN 4 VERTEBRAE. IN ONE CASE WITHOUT ANY POSTERIOR VERTEBRAL WALL INJURY, CEMENT EXTRAVASATION INTO THE SPINAL CANAL WAS DETECTED IN L3 AT 1 WEEK POST-OP USING A POSTOPERATIVE CT AND XP. ACCORDING TO THE REPORT, CEMENT LEAKAGE WAS MONITORED UNDER FLUOROSCOPIC VISUALIZATION AND IMMEDIATELY STOPPED FILLING THE CEMENT WHEN THE CEMENT WAS FOUND AT THE POSTERIOR OF ANTERIOR TWO-THIRDS OF THE VERTEBRAL BODY. THIS PATIENT ALSO "EXPERIENCE REDUCTION WITH CURETTE" AND "BOTH BALLOON INFLATION VOLUME AND CEMENT FILLING VOLUME WAS 3ML. POSTOPERATIVE NEUROLOGICAL FINDINGS WERE NOT OBSERVED", PER THE REPORT. NO PATIENT COMPLICATIONS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360516 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR BKP