BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCP 3.5 10HO L122 SST

    MDR report key: 3182732 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03543
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    July 4, 2012
    Report Date
    August 6, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. (B)(6). NO PRODUCT FAULT COULD BE DETECTED. BASED ON THE COMPLAINT DESCRIPTION THE EXACT CAUSE OF THE BREAKAGE CAN NOT BE DETERMINED. IT CAN ONLY BE PRESUMED THAT THE POST OPERATIVE ACTIVITIES CAUSED A FATIGUE FAILURE. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VETERINARY PLATE BROKE IN SITU. THE DOG JUMPED OUT OF A CAR, THE MIDSHAFT TIBIA AND FIBULA WERE FRACTURED THIS WAS A UNSTABLE FRACTURE. A 3.5 DCP PLATE WAS PLACED ON THE TIBIA WITH EIGHT 3.5 SCREWS AND ONE 4.5 SCREW. THE MOST DISTAL SCREW HOLE WAS DULL SO A 4.5 SCREW WAS PLACED INSTEAD OF A 3.5 CORTEX SCREW. AFTER ONE WEEK OF SURGERY, THE WOUND HEALED WITHOUT ANY COMPLICATIONS. TWO WEEKS AFTER SURGERY, THE PAWS FELT A BIT WARM, WITH SOME FLUID COMING OUT OF THE WOUND. THE PAW AND KNEE WERE SOMEWHAT EXOROTATED, THE PLATE BROKE FOUR WEEKS POST OPERATION AT THE FRACTURE LINE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283590 DCP 3.5 10HO L122 SST HRS SYNTHES GMBH 1186

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention