BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHX INFLATABLE BONE TAMP

    MDR report key: 1712819 · Received June 4, 2010

    Report

    Report Number
    2953769-2010-00211
    Event Type
    Death
    Date Received
    June 4, 2010
    Date of Event
    November 16, 2009
    Report Date
    May 14, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED, "TUBERCULOUS SPONDYLITIS AND PARAVERTEBRAL ABSCESS FORMATION AFTER KYPHOPLASTY" BY ROLAND IVO, MD, ROLF SOBOTTKE, MD, HARALD SEIFERT, MD, MONIKA ORTMANN, MD, PEER EYSEL, MD. DEVICE NOT RETURNED, FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "TUBERCULOUS SPONDYLITIS AND PARAVERTEBRAL ABSCESS FORMATION AFTER KYPHOPLASTY", THE FOLLOWING EVENT WAS REPORTED: A PHYSICIAN PERFORMED A BALLOON KYPHOPLASTY PROCEDURE IN LEVEL L1 IN A PATIENT WITH AN UNDIAGNOSED PULMONARY AND POSSIBLE SPINAL TUBERCULOSIS. TWO WEEKS POST PROCEDURE, THE PT PRESENTED WITH FEVER AND GENERAL WEAKNESS. AN MRI SCAN REVEALED L1 SPONDYLITIS AND PARAVERTEBRAL ABSCESS FORMATION PROMPTING INTENSIVE ANTIBIOTIC THERAPY, HOWEVER, WITHOUT ANY IMPROVEMENT. EXTENSIVE REVISION SURGERY WITH LAMINECTOMY, POSTERIOR INSTRUMENTATION AND DISC RESECTION WERE PERFORMED, HOWEVER, THE DISCAL BIOPSY BROUGHT ONLY NONSPECIFIC RESULTS. ONLY A SECOND SURGICAL INTERVENTION WITH CORPORECTOMY WITH SUBSEQUENT HISTOLOGIC EXAMINATION POINTED TO A TUBERCULOUS INFECTION CONFIRMED BY PCR AND CULTURES. DESPITE SPECIFIC ANTITUBERCULOSIS TREATMENT, A PSOAS ABSCESS AND A SUPRAINFECTION WITH A RESISTANT (B) (6) DEVELOPED, LEADING TO SEPSIS WITH MULTIPLE ORGAN FAILURE AND DEATH. NO ADD'L INFO WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening PRE/POSTOPERATIVE. ANTITUBERCULOTIC TREATMENT:| ISONIAZID| ETHAMBUTOL/ANTIMICOBIAL (LINEZOLID): POSTOPERATIVE| ANTIBIOTIC THERAPY (CIPROFLOXACIN:| PYRAZINAMID,| RIFAMPICIN