BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3260363 · Received August 1, 2013

    Report

    Report Number
    1030489-2013-03174
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    July 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    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 INJURY INFLUENCE THE SAFETY DURING BALLOON KYPHOPLASTY". JOURNAL OF SPINE RESEARCH. VOL. 4, NO. 6; 2013: P 1024-1027. (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. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    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 CEMENT 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 POSTERIOR VERTEBRAL WALL INJURY, A PATIENT "HAD A TEMPORAL HYPOXEMIA (SP02: 60%) JUST AFTER BKP, BUT RECOVERED IN TEN MINUTES AND HAD NO SYMPTOMS AFTER DECANNULATION". NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359774 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention HV-R CEMENT