BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE CEMENT

    MDR report key: 1920317 · Received December 10, 2010

    Report

    Report Number
    2953769-2010-00597
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    July 30, 2006
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "REVISION SURGERY AFTER VERTEBROPLASTY OR KYPHOPLASTY", BY KEE-YONG HA, MD, KI-WON KIM, MD, YOUNG-HOON KIM, MD, IN-SOO OH, MD, SANG-WON PARK, MD METHOD: DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "REVISION SURGERY AFTER VERTEBROPLASTY OR KYPHOPLASTY", THE FOLLOWING WAS REPORTED: SIX PATIENTS UNDERWENT KYPHOPLASTY BETWEEN (B)(6) 2001 AND (B)(6) 2006. THE AVERAGE TIME TO REVISION WAS 15 MONTHS (RANGE, 3 TO 70 MONTHS). CASE 1: (B)(6)/F, TREATED FOR OCF AT LEVEL L2. ANTERIOR AND POSTERIOR FUSION PERFORMED 24 MONTHS POST-OP DUE TO INFECTION. CASE 2: (B)(6)/M, TREATED FOR OCF AT LEVEL D12. LAMINECTOMY PERFORMED 15 MONTHS POST-OP DUE TO PROGRESSIVE KYPHOSIS. CASE 3: (B)(6)/M. TREATED FOR OCF AT L1. ANTERIOR FUSION PERFORMED 3 MONTHS POST-OP DUE TO INFECTION, WHICH WAS MISDIAGNOSED PREOPERATIVELY. CASE 4: (B)(6)/F, TREATED FOR OCF AT L1, 2. ANTERIOR AND POSTERIOR FUSION PERFORMED 6 MONTHS POST-OP DUE TO INFECTION. CASE 5: (B)(6)/F, TREATED FOR OCF AT D12. ANTERIOR AND POSTERIOR FUSION PERFORMED 3 MONTHS POST-OP DUE TO PROGRESSIVE KYPHOSIS. CASE 7: (B)(6)/F, TREATED FOR OCF AT L1, 3. ANTERIOR AND POSTERIOR FUSION PERFORMED 18 MONTHS POST-OP DUE TO INFECTION, WHICH WAS MISDIAGNOSED PREOPERATIVELY. DEATH DUE TO SEPSIS AND METASTATIC CANCER WAS NOTED. CASE 11: (B)(6)/F, TREATED FOR OCF AT D11, 12. ANTERIOR AND POSTERIOR FUSION PERFORMED 8 MONTHS POST-OP DUE TO PROGRESSIVE KYPHOSIS. THIS PATIENT HAD UNDERGONE PKP FOR AN UNSTABLE BURST FRACTURE AT ANOTHER INSTITUTE. INITIALLY, THE PATIENT HAD REFUSED A MAJOR OPERATION FOR RELIGIOUS REASONS. NO FURTHER INFORMATION WAS REPORTED. NOTE: MEDTRONIC PRODUCT IS NOT CURRENTLY DISTRIBUTED IN (B)(4). IT IS ALSO NOTED THAT THE CASES TOOK PLACE BETWEEN 2001 AND 2006; HOWEVER, HV-R BONE CEMENT WAS NOT AVAILABLE UNTIL 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention