BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT

    MDR report key: 3020758 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10535
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    August 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DHR WAS REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MACROSCOPIC ASSESSMENT REVEALED DISCOLORED AREAS AT THE LASER ETCHINGS AT ALL FIVE IMPLANTS. THE DISCOLORATIONS WERE RED, BROWN AND BLUE ON THE DIFFERENT ANALYZED AREAS. THE RED AND BROWN DISCOLORATION COULD BE IRON OXIDE, PROBABLY FROM UNFAVORABLE LASER PARAMETER OR AN INSUFFICIENT PROTECTIVE GAS DELIVERY DURING LASER ETCHING. THE EXAMINATION OF THE LASER MARKS BY THE SCANNING ELECTRON MICROSCOPE (SEM) REVEALED MATERIAL FLAKING IN AND BESIDES THE LASER MARKS ON THE MAJORITY OF THE IMPLANTS. ON THE PLATES, SEVERAL HOLES COULD BE DOCUMENTED IN THE LASER MARKS, IT CAN BE ASSUMED THAT THE LASER BEAM STOPPED FOR A SHORT MOMENT AND BURNED HOLES. THE X-RAY SPECTROSCOPIC (EDX) INVESTIGATION OF THE DISCOLORED AREAS REVEALED BESIDE THE STAINLESS STEEL COMPOSITION, A HIGH FRACTION OF OXYGEN. THE OXYGEN WAS PRESENT IN THE ENTIRE LASER ETCHINGS, WITH BIGGER PROPORTION AT THE SURFACE WITHOUT FLAKING. IT CAN BE ASSUMED THAT THE LASER ETCHING CREATED AN UNCONTROLLED LAYER OF COMBUSTION PRODUCTS. THE TENSION IN THIS LAYER CONDUCTED TO THE DELAMINATIONS. THE CLINICAL PROCESSING COULD CAUSE INCREASED TENSIONS DUE TO USED CHEMICALS LIKE DISINFECTANTS AND DETERGENTS AND INCREASED TEMPERATURE ETC. LEADING TO THE OBSERVED DELAMINATIONS OF THE COMBUSTION PRODUCT LAYER.

    Additional Manufacturer Narrative · 1

    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. THE INVESTIGATION REVEALED THE CAUSE OF DAMAGE TO THE PLATES AS: THE FIVE VA-LCP CONDYLAR PLATES SHOWED DISCOLORED AREAS AT THE LASER MARKS. THE DISCOLORATIONS WERE IRON OXIDE LAYER PROBABLY COMBUSTION PRODUCTS INITIATED BY UNFAVORABLE LASER PARAMETERS DURING LASER ETCHING. THE REASON FOR UNCONTROLLED COMBUSTION PRODUCT FORMATION COULD BE AN INSUFFICIENT PROTECTION GAS ATMOSPHERE DURING PROCESS OR UNFAVORABLE LASER ETCHING PARAMETERS FOR EXAMPLE INAPPROPRIATE FOCUS DISTANCE, POWER OR IRREGULAR DISPLACEMENT OF THE LASER HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLATES ARE RUSTED AFTER GOING THROUGH AUTOCLAVE CYCLE. RUST SEEMS TO BE LOCATED WHERE SIDE MARKER (L OR R) IS ETCHED INTO PLATE. RUST APPEARED ON SEVERAL OF THE PLATES IN THE SET. ONE OF THE UNRUSTED PLATES WAS IMPLANTED WITH NO PROBLEM. THIS IS 4 OF 5 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 5 FOR THIS (B)(4). THE IMPLANTED PLATE REFERRED TO IN THE INITIAL REPORT WAS NOT ONE OF THE 5 PLATES WITH ALLEGED RUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123592 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT JDP SYNTHES GMBH 7553094

    Patients

    Seq Age Sex Outcome Treatment
    1