BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCP 3.5 STRENGTHENED 11HO L134 SST

    MDR report key: 2981691 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00652
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MACROSCOPIC INVESTIGATION SHOWED DAMAGED AND DISCOLORED AREAS AT SOME OF THE SCREW HOLES AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THE DCP PLATE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. THE PLATE WAS MADE FROM IMPLANT GRADE STAINLESS STEEL AND WAS ALSO ELECTRO POLISHED TO BE MORE RESISTANT TO CORROSION. WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DISCOLORED AREAS ON THE PLATE WERE BLOOD AND TISSUES RESIDUES COMBINED WITH CORRODED METALLIC PARTICLES. FROM A X-RAY SPECTROSCOPIC DETECTION PERSPECTIVE NO CLEAR EVIDENCE CAN BE FOUND THAT THE METALLIC PARTS MAY ORIGIN FROM FRICTION OR FROM AN INSTRUMENT. HOWEVER, THIS IS INDICATIVE OF THE FACT THAT CONTACT OF THE SCREWS AND PLATE AND THUS A MICRO MOVEMENT AGAINST EACH OTHER MIGHT HAVE LED TO CORROSION OF THE METALLIC DEBRIS. IT CANNOT BE FULLY EXCLUDED THAT THE METALLIC PARTS ORIGINS FROM AN INSTRUMENT PART LIKE A DRILL BIT OR A DRILL GUIDE. IT THE RESIDUES ORIGIN FROM THE DRILL BIT, THEY WOULD BE MORE SUSCEPTIBLE TO CORROSION BECAUSE THEY FORM A GALVANIC ELEMENT TO THE IMPLANT. CORROSION WOULD BE TRIGGERED ADDITIONAL BY A VERY UNFAVORABLE SURFACE RATION BETWEEN ANODE AND CATHODE. THIS INSTRUMENT RESIDUE SCENARIO SHOULD BE STILL TAKEN INTO ACCOUNT. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE IS A VETERINARY PRODUCT AND DOES NOT HAVE A 510(K) NUMBER. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A VETERINARIAN IN (B)(6) REPORTED HE REMOVED A PLATE AFTER SEVERAL WEEKS FROM A YOUNG DOG THAT IS STILL IMMATURE AND GROWING. UPON REMOVAL, HE NOTED A BROWN/BLACK DISCOLORATION AT THE 4TH HOLE OF THE PLATE AND AT THE TRANSITION OF THE SHAFT/HEAD OF THE CORTEX SCREW. THERE WAS NO INFECTION INSIDE THE PATIENT. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83461 DCP 3.5 STRENGTHENED 11HO L134 SST PLATE GXN SYNTHES GMBH 2252664

    Patients

    Seq Age Sex Outcome Treatment
    1