BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VET LCP 3.5 12HO L157 SST

    MDR report key: 3212890 · Received July 9, 2013

    Report

    Report Number
    3003506883-2013-00297
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PMA/ 510K#: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE PLATE IS MADE OF STAINLESS STEEL. THE EXAMINATION OF THE MANUFACTURING DOCUMENTS OF THE PRODUCER AND THE RAW-MATERIAL INSPECTION SHEET OF THE SUPPLIER SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL OF THE PLATE IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS FOR IMPLANTS MADE OF STAINLESS STEEL. THE DIMENSIONS OF THE INVESTIGATED PLATE (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALIPER AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO/ASIF SPECIFICATIONS. A MACROSCOPIC VISIBLE FATIGUE CRACK IS DOCUMENTED AT THE SIXTH, DISTAL PLATE HOLE AT THE THREADED PART OF THE COMBINATION PLATE HOLE AND INDICATES MULTIPLE CRACK INITIATION. THE FRACTURE SURFACES ARE STRONGLY ABRADED. SEM OBSERVATIONS AND FINDINGS SHOWED THAT THE PLATE FAILURE WAS CAUSED BY FATIGUE AND OVERLOAD. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, THERE IS EVIDENCE OF THE IMPLANT WAS SUBJECTED TO LOW DYNAMIC LOADS. CONSTANTLY ALTERNATING BENDING LOADS (DURING WALKING OR MOVEMENT OF THE DOG) LED TO THE FATIGUE OF THE MATERIAL, THEN TO AN INITIAL CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE PLATE. THE PLATE COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE DOG HAVE PLAYED A CERTAIN ROLE, TOO. THERE IS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS A VETERINARY EVENT. THE PLATE BROKE POST OPERATIVELY ON AN UNKNOWN DATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313494 VET LCP 3.5 12HO L157 SST HRS SYNTHES ELMIRA 7198126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention