BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR END PLATE LARGE-STERILE

    MDR report key: 4092378 · Received September 16, 2014

    Report

    Report Number
    2530088-2014-10274
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING PRODUCTION. UDI #(B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEG PAIN, DIAGNOSED WITH DEGENERATIVE DISC DISEASE, AND HAD UNDERGONE A 2-LEVEL TOTAL DISC REPLACEMENT WITH PRODISC-L AT L3-L5 ON (B)(6) 2014. DURING THE PROCEDURE, AS THE SURGEON INSERTED THE IMPLANT INTO THE OPERATIVE DISC SPACE AT L4-5, THE BOTTOM TWO PRONGS OF THE INSERTER BROKE OFF INTO THE INFERIOR END PLATE. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THIS RESULTED IN A ONE-HOUR DELAY. REPORTEDLY, THAT THE EVENT DID NOT RESULT IN ANY ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT NUMBER 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573234 INFERIOR END PLATE LARGE-STERILE PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE 7453179

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention