BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L26 TI

    MDR report key: 3091607 · Received May 3, 2013

    Report

    Report Number
    8030965-2013-02098
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K971883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN OPERATION FOR DISTAL TIVIA ON (B)(6) 2013, THE DOCTOR INSERTED BOTH A 3.5 CORTICAL SCREW AND 4.0 CANCELLOUS SCREW WITHOUT CUTTING A THREAD WITH A TAP. THE SCREWS BROKE AS A RESULT. NO IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194853 CORTSCR Ø3.5 L26 TI KWQ SYNTHES GMBH 8048570

    Patients

    Seq Age Sex Outcome Treatment
    1