BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø4.5 L34 SST

    MDR report key: 3193420 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04159
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 1, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K974537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE MEASURABLE DIMENSIONS OF THE RETURNED SCREWS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE VALUES WERE ALSO IN COMPLIANCE WITH INTERNATIONAL STANDARDS. NO PRODUCT FAULT COULD BE DETECTED. THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE. (B)(4).

    Description of Event or Problem · 1

    SCREW BENT DURING INSERTION, METAL SHAVING CAME OFF. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291651 CORTSCR Ø4.5 L34 SST KTT SYNTHES GMBH 3682581

    Patients

    Seq Age Sex Outcome Treatment
    1