BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOW PROFILE NEURO SCREWSELF-DRILLING 5MM

    MDR report key: 3962268 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12854
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: SCREW IS BROKEN OFF. SINCE THE EXACT LOT NUMBER IS NOT KNOWN THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED AND WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE DAMAGE INCURRED. IT IS LIKELY THAT MECHANICAL OVERLOADING HAS RESULTED IN THE BREAKAGE. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING SURGERY FOR A FRONTAL TUMOR (GLIOMA) THE SURGEON MADE A CRANIOTOMY FRONT 7 X 7 CM, AND IMPLANTED THE SYSTEM NEURO 1.6 COMPACT 5MM LENGTH. THE TUMOR COULD BE REMOVED WITHOUT INCIDENT. DURING THE REDUCTION OF THE BONE PLATE, THREE SCREWS BROKE. THIS REPORT IS FOR THE 3RD OF THE 3 BROKEN SCREWS THIS IS REPORT 3 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439452 TI LOW PROFILE NEURO SCREWSELF-DRILLING 5MM BONE PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR