BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAPFIX TEXTURED Ø13 TI

    MDR report key: 2993687 · Received March 7, 2013

    Report

    Report Number
    2520274-2013-01333
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    GXN
    PMA / PMN Number
    K992000
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IT IS CLEARLY VISIBLE THAT THE LOWER PLATE HAS BEEN COMPLETELY DETACHED FROM THE ROD. THE MIDDLE OF THE ROD IS ALSO BADLY COMPRESSED. THIS LEAD US BELIEVE THAT THE DAMAGES WERE CAUSED USING THE APPLIC-FORCEPS WHICH LIFTED AND COMPLETELY RIPPED THE ROD FROM THE LOWER PLATE. FURTHER INVESTIGATION SHOWED CONFORMITY OF THE ARTICLE IN QUESTION TO THE COMPANY SPECIFICATION AND NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT DURING SURGERY ON (B)(6) 2013, SURGEON WAS TRYING TO FIX A CRANIAL FLAP TUBE CLAMP WITH THE NEW APPLICATION FORCEPS, AND THE CRANIAL FLAP TUBE CLAMP BROKE. IT IS REPORTED THAT THE BOTTOM DISC BROKE AWAY FROM THE CLAMP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97179 FLAPFIX TEXTURED Ø13 TI GXN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1