BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 10204857 · Received June 29, 2020

    Report

    Report Number
    1030489-2020-00741
    Event Type
    Injury
    Date Received
    June 29, 2020
    Report Date
    June 29, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: OTHER: FRACTURE. 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 WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PT DEMOGRAPHICS: TOTAL PATIENT - 139, MEAN AVERAGE AGE- 73 YEARS, AND 82% OF THE PATIENTS WERE FEMALES (MALE- 20, FEMALE- 93). IT WAS REPORTED VIA LITERATURE TITLED "PERCUTANEOUS VERTEBROPLASTY AND BALLOON KYPHOPLASTY IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURES: A PROSPECTIVE RANDOMIZED COMPARISON¿ THAT POST-OP, A TOTAL OF 139 PATIENT WERE ELIGIBLE FOR RANDOMIZATION {N = 70 FOR PVP (PERCUTANEOUS VERTEBROPLASTY) GROUP AND N = 69 FOR BKP (BALLOON KYPHOPLASTY) AND TWENTY-SIX PATIENTS (TWENTY IN THE BKP GROUP AND SIX IN THE PVP GROUP) WERE EXCLUDED. THESE PROCEDURE PERFORMED IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES (PATIENTS WERE RANDOMIZED BETWEEN 2011 AND 2015). THIRTY-NINE PATIENTS HAD A FRACTURE IN TWO OR THREE LEVELS. IN PARTICULAR, 22% OF ALL FRACTURES AFFECTED T4¿T10 LEVELS, 45% AFFECTED THE THORACO-LUMBAR JUNCTION (T11¿L1) AND 33% WERE AT L2¿L5 LEVELS. THE RATE OF CEMENT LEAKAGE IN OUR STUDY WAS 4.5% AND NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS. FIFTEEN OF 64 PATIENTS (23%) HAD NEW FRACTURES AND REINTERVENTION AFTER VERTEBROPLASTY COMPARED TO TWO OF 49 PATIENTS (4%) AFTER KYPHOPLASTY (P = 0.0043). EIGHT PATIENTS HAD ONLY ONE FRACTURE, WHILE THE OTHER PATIENTS HAD MULTIPLE FRACTURES. THREE OF THEM WERE ADMITTED AND SURGICALLY TREATED TWICE DURING THE FOLLOW-UP PERIOD. DURING FOLLOW-UP, WE REGISTERED A TOTAL OF FORTY NEW FRACTURES IN 113 PATIENTS AND AMONG THESE, TWELVE HAVE FRACTURES ON THE LEVEL ADJACENT TO THE TREATED LEVEL. ELEVEN CASES OF ADJACENT FRACTURES OCCURRED IN THE PVP GROUP AND ONE CASE IN THE BKP GROUP. A YEAR VAS PAIN SCORE WAS SIGNIFICANTLY REDUCED AFTER SURGERY IN BOTH GROUPS, AND THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS IN POSTOPERATIVE VAS SCORE. ODI SCORES WERE SIGNIFICANTLY DECREASED IN BOTH GROUPS AFTER INTERVENTION, AND THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE TWO GROUPS. ADVERSE EVENTS: ADJACENT FRACTURES, VERTEBRAL COMPRESSION FRACTURE (VCF)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672402 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other