BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VET DCP 3.5 8HO L97 SST

    MDR report key: 3093184 · Received May 4, 2013

    Report

    Report Number
    3003506883-2013-00210
    Event Type
    Malfunction
    Date Received
    May 4, 2013
    Report Date
    October 29, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REPORT 1 OF 2 FOR #(B)(4) TO INCLUDE INITIAL FOR UNKNOWN SCREW. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A 510K#: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. INVESTIGATION COORDINATED BY SYNTHES (B)(6). REPORT RECEIVED INDICATES THE DIMENSIONS OF THE PLATE WERE CHECKED (AS FAR AS MEASURABLE) AND FOUND TO BE IN ACCORDANCE WITH THE TECHNICAL DRAWINGS. THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEETS AND THE MANUFACTURING PAPERS SHOWS THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES OF THE PLATE ARE IN COMPLIANCE WITH (B)(4) SPECIFICATIONS AND THE INTERNATIONAL STANDARDS. A PATTERN OF RIPPLES OR FATIGUE STRIATIONS WAS OBSERVED AT THE CRACK PROPAGATION ZONE AND ALMOST OVER THE ENTIRE FRACTURE SURFACE. THE PLATE MOST LIKELY BECAME HIGHLY STRESSED DURING THE FUNCTIONAL POSTOPERATIVE AND FOLLOW-UP PHASE. THE PLATE HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. NO MATERIAL DEFECT DETECTED. FURTHER, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR #(B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN THE (B)(6): A CANINE WAS SUFFERING FROM A LEFT FEMUR AND LEFT HUMERUS FRACTURE. THE VETERINARY IMPLANTED, ON AN UNKNOWN DATE, A SMALL FRAGMENT VET DYNAMIC COMPRESSION PLATE (DCP) TO REPAIR THE FEMORAL SHAFT FRACTURE. THE EVENT OCCURRED POSTOPERATIVELY, AND AFTER CANINE WAS PUT ON SIX WEEKS OF BENCH REST, AS WELL AS SIX WEEKS OF SHORT LEASH. IT WAS REPORTED CANINE WAS IMPLANTED WITH DCP PLATE AT THE LATERAL SITE WITH POLYPARADIOXANONE (PDS) CERCLAGE. IT WAS ALSO REPORTED THE DEVICE WILL BE RETURNED TO THE OWNER OF THE DOG. THIS REPORT IS FOR A 3.5MM DCP PLATE, 8 HOLES/97MM. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT 35172.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195702 VET DCP 3.5 8HO L97 SST HRS SYNTHES ELMIRA 6569751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention