BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAPFIX TEXTURED Ø18 TI

    MDR report key: 3173871 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03260
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    September 1, 2011
    Report Date
    September 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GXN
    PMA / PMN Number
    K992000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL NARRATIVE: THE EXPIRATION DATE IS 04/11/2021 (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE LOWER DISC IS BROKEN, AND THERE ARE MARKS ON THE DEVICE. THE MEASURABLE DIMENSIONS OF THE RETURNED FLAPFIX IMPLANT WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH LED TO THE DAMAGE. THE VISIBLE MARKS ARE EVIDENCE THAT TOO MUCH APPLIED FORCE, DURING SURGERY, CAUSED THE SEPARATION OF THE LOWER DISC FROM THE SYSTEM. NO MANUFACTURING PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY OF BRAIN ANEURYSM A LOWER DISK BROKE OFF. THE DOCTOR USED ANOTHER DISK AND FINALIZED THE OPERATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272884 FLAPFIX TEXTURED Ø18 TI GXN SYNTHES GMBH 3773999

    Patients

    Seq Age Sex Outcome Treatment
    1