BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 2807685 · Received October 29, 2012

    Report

    Report Number
    2953769-2012-00157
    Event Type
    Injury
    Date Received
    October 29, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K093828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: JEFFREY FORRIS BEECHAM CHICK, NIKUNJ RASHMIKANT CHAUHAN, KATHERINE MARIE MULLEN, RYAN JAMES BAIR, BHARTI KHURANA. PULMONARY CEMENT EMBOLI AFTER KYPHOPLASTY. INTERN EMERGMED 2012; (DOI 10.1007/S11739-012-0847-0). DATE OF EVENT IS UNKNOWN. (B)(6). (B)(4). PULMONARY EMBOLISM; CEMENT EXTRAVASATION. UNKNOWN RADIOLOGY. FILMS INTERPRETATION: "T1 SAGITTAL MRI - ABNORMAL PRE-OP STUDIES SHOWING LESIONS AT L1 <(>&<)> L2 WITH COLLAPSE. POST-CEMENTING LATERAL FLUORO VIEWS WITH CEMENT IN PLACE. NO EVIDENCE OF EXTRAVASATION. CHEST CT AND X-RAY SHOW SEVERAL SMALL FRAGMENTS OF CEMENT WITH PULMONARY VASCULATURE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CASE STUDY WAS CONDUCTED ON A PATIENT PRESENTING WITH SEVERE LOWER BACK PAIN. MRI OF THE SPINE DEMONSTRATED ANTERIOR WEDGE COMPRESSION DEFORMITIES OF THE L1 AND L2 VERTEBRAL BODIES. THE PATIENT UNDERWENT A BILATERAL TRANSPEDICULAR KYPHOPLASTY WITHOUT EVIDENCE OF CEMENT EXTRAVASATION. ONE MONTH LATER, AFTER AN "UNEVENTFUL RECOVERY", THE PATIENT RETURNED TO THE HOSPITAL WITH PLEURITIC CHEST PAIN, SHORTNESS OF BREATH, AND GENERALIZED WEAKNESS FOR 4 DAYS. ACCORDING TO THE REPORT, CT IMAGES OF THE CHEST WITH PULMONARY ANGIOGRAPHY PROTOCOL WERE COMPLETED AND DEMONSTRATED "NUMEROUS LINEAR HYPERDENSITIES THROUGHOUT THE ARTERIAL TREE, CONSISTENT WITH PULMONARY CEMENT EMBOLI FROM THE PRIOR KYPHOPLASTY AS WELL AS MULTIPLE HYPODENSE FILLING DEFECTS REPRESENTING ASSOCIATED THROMBI." THE PATIENT WAS ADMITTED AND BEGAN TREATMENT WITH ENOXAPARIN AND WAS LATER DISCHARGED WITH PLANS TO CONTINUE VINORELBINE TREATMENTS. IT WAS REPORTED THAT ONE MONTH LATER DURING A RETURN CLINIC VISIT, THE PATIENT REPORTED COMPLETE RESOLUTION OF CHEST PAIN, SHORTNESS OF BREATH, AND WEAKNESS, WITH MILD IMPROVEMENT OF BACK PAIN. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MEDTRONIC SPINE LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| L| R BKP