BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VET LCP 2.4 12HO L96 T2 SST

    MDR report key: 3193372 · Received June 27, 2013

    Report

    Report Number
    3003506883-2013-00280
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    September 21, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    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. THE DEVICE LISTED IN THIS REPORT IS 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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EXAMINATION OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO APPARENT FAULT OF MATERIAL OR MANUFACTURING WAS DETECTED. BASED ON THE X-RAY IMAGES WE ASSUME THAT THE IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. BECAUSE OF THE COMMINUTED BONE FRACTURE THE PLATE HAD TO ACT AS A SINGLE STABILIZER. POSTOPERATIVE ACTIVITIES OF THE DOG MAY HAVE CERTAINLY PLAYED A CERTAIN ROLE TOO. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. BASED ON THE COMPLAINT DESCRIPTION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE AND CAN ONLY ASSUME THAT POSTOPERATIVE ACTIVITIES OF THE DOG MAY HAVE CERTAINLY PLAYED A CERTAIN ROLE.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VET LCP PLATE BENT OVER EMPTY SCREW HOLE. THE LCP 2.4 WAS DEFORMED IN THE MIDDLE AND DISTAL AREA OF THE DOG WHO WAS SUFFERING FROM A LEFT COMMINUTED TIBIA FRACTURE AND A FRACTURE OF THE FIBULA. ON THE (B)(6) 2012 THE TIBIA FRACTURE WAS TREATED BY MEANS OF THE COMPLAINED LCP 2.4 WITH 12 HOLES WHICH GOT BENT OVER THE EMPTY SCREW HOLES. THE PLATE WAS FIXED WITH 4 SCREWS IN THE PROXIMAL AREA AND WITH FOUR SCREWS IN THE DISTAL AREA. THE PLATE WAS REMOVED AND REPLACED BY A NEW 12 HOLE LCP 2.4 PLATE. THERE WAS NO REPORT TO THE AFTER CARE OF THE DOG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293748 VET LCP 2.4 12HO L96 T2 SST HRS SYNTHES ELMIRA 6991467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention