BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 2250524 · Received September 15, 2011

    Report

    Report Number
    2953769-2011-00120
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 22, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). REPORT SOURCE: ARTICLE TITLED "BACK TROUBLE" BY COLLEEN HEILD. EVAL METHOD: FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "BACK TROUBLE", 47 FORMER PATIENTS HAVE FILED LAWSUITS AGAINST (B)(6). THE LAWSUITS RELATE "TO PROCEDURES THAT HAVE NOT BEEN PERFORMED AT THE HOSPITAL FOR NEARLY THREE YEARS, BY PHYSICIANS WHO NO LONGER WORK AT THE HOSPITAL. THE PROCEDURE IS COMMONLY KNOWN AS PLEXIGLASS, WAS NOT AN APPROVED TREATMENT IN HUMANS AND DID NOT WORK WHEN USED IN EXPERIMENTS ON PIGS". THE "PLEXIGLASS SURGERY WAS DESCRIBED AS AN ALTERATIVE TO TRADITIONAL DISC FUSION SURGERY. THE PRIMARY SUBSTANCE IN THE INJECTIONS IS POLYMETHYLMETHACRYLATE, PMMA. THE CEMENT-LIKE PLEXIGLASS WOULD BE HEATED, COMBINED WITH AN ANTIBIOTIC AND BARIUM, INJECTED INTO THE SPACE BETWEEN COMPRESSED OR COMPROMISED DISCS AND LATER HARDEN. THE LAWSUITS ALLEGE THAT THE SLURRY ENDED UP LEAKING, FRACTURING, DISINTEGRATING AND MIGRATING ELSEWHERE, DAMAGING NERVE STRUCTURES AND BONE. ONCE INJECTED THE PLEXIGLASS IS VIRTUALLY IMPOSSIBLE TO COMPLETELY REMOVE FROM DISC SPACE". THE LAWSUITS STATE THAT NOW PATIENTS CONTEND THEY HAVE SUFFERED PERMANENT INJURY AND ARE IN CONSTANT PAIN, SINCE THE SURGERIES. THEY RELY ON NARCOTIC MEDICATION OR OTHER PAIN-RELIEVING REMEDIES. THE ARTICLE DOES NOT MAKE DIRECT REFERENCE TO MEDTRONIC PRODUCTS; HOWEVER, A MEDTRONIC SALES REP ALLUDED THAT THE ACCESS TOOLS AND IBTS MAY HAVE BEEN USED BY THE PHYSICIAN. PRODUCTS WERE USED TO ACCESS THE DISC SPACE AND INJECT BONE CEMENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SPINE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other