BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 6968983 · Received October 23, 2017

    Report

    Report Number
    2520274-2017-12498
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 11, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KAN, P. AND SCHMIDT, M. (2008) MINIMALLY INVASIVE THORACOSCOPIC APPROACH FOR ANTERIOR DECOMPRESSION AND STABILIZATION OF METASTATIC SPINE DISEASE. NEUROSURG FOCUS, VOLUME 25(2): E8. THIS REPORT IS FOR UNKNOWN ¿ SYNEX CAGE/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. IMPLANT/EXPLANT DATE: UNKNOWN. PART # IS UNKNOWN, 510K IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE KAN, P. AND SCHMIDT, M. (2008) MINIMALLY INVASIVE THORACOSCOPIC APPROACH FOR ANTERIOR DECOMPRESSION AND STABILIZATION OF METASTATIC SPINE DISEASE. NEUROSURG FOCUS, VOLUME 25(2): E8. THE PURPOSE OF THIS ARTICLE IS TO DESCRIBE THE APPLICATION OF A MINIMALLY INVASIVE PROCEDURE FOR THE SURGICAL TREATMENT OF METASTATIC SPINAL CORD COMPRESSION AND PATHOLOGICAL FRACTURES IN THE THORACOLUMBAR SPINE, WITH AN EMPHASIS ON RECENTLY DEVELOPED RECONSTRUCTION AND STABILIZATION TECHNIQUES. THIS STUDY OCCURRED BETWEEN 2002 AND 2007 WHERE 34 PATIENTS WITH VARIOUS PATHOLOGIES INVOLVING THE THORACIC AND THORACOLUMBAR SPINE UNDERWENT THORACOSCOPIC VERTEBRECTOMY. OF THESE PATIENTS, FIVE (5) PRESENTED WITH METASTATIC DISEASE OF THE THORACIC SPINE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ¿ SYNEX CAGE AND REFERS TO PATIENT 4 (MALE, (B)(6) YEARS) WHO HAD PAIN FROM A PELVIC METASTASIS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749632 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention