BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    MDR report key: 4275803 · Received November 25, 2014

    Report

    Report Number
    2520274-2014-14946
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    October 15, 2014
    Report Date
    November 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING THE T-PAL-EXPEDIUM SURGERY ON (B)(6) 2014, THE DURA WAS INJURED FOR A SECOND TIME, ON AREA OF LWK 4-5, BY IMPROPER REMOVAL OF THE TRIAL IMPLANT. PREVIOUSLY THE DURA WAS INJURED BASED ON THE HEAVY SITUS. REPORTEDLY THE INJURY IS NOT BASED ON THE INSTRUMENTS/IMPLANTS AND WAS USER ERROR. THE INCIDENT CAUSED A PROLONGATION OF THE SURGERY, BUT IT IS NOT KNOWN HOW LONG. THIS REPORT IS FOR THE UNKNOWN T-PAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763856 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention