BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 12DEG-STER

    MDR report key: 3864130 · Received June 10, 2014

    Report

    Report Number
    9612488-2014-10213
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    MAX
    PMA / PMN Number
    PK072253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 AN ANTERIOR LUMBAR INTER-BODY FUSION THE SURGEON HAD DIFFICULTY SCREWING THREE DIFFERENT SCREWS INTO THE PLATE. THE FOURTH SCREW USED WAS ABLE TO SECURE THE PLATE. THIS RESULTED IN A 20 MINUTE DELAY IN SURGERY; NO ADVERSE EVENT WAS REPORTED WITH THE PATIENT. THIS IS REPORT 1 OF 3. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337741 SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 12DEG-STER INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX SYNTHES BETTLACH 8781749

    Patients

    Seq Age Sex Outcome Treatment
    1