BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTSCR Ø3.5 SELF-TAP L30 SST

    MDR report key: 2993839 · Received March 8, 2013

    Report

    Report Number
    1719045-2013-00489
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    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. DEVICE WAS USED FOR A VETERINARY PROCEDURE. DEVICE WAS USED AS A VETERINARY PRODUCT. DEVICE IS MARKETED FOR HUMAN USE. HEALTH PROFESSIONAL IS VETERINARY PERSONNEL. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT SERVICE: ADDITIONAL INFORMATION. NO PRODUCT FAULT COULD BE DETECTED. NEITHER THE ARTICLE- NOR THE LOT NUMBER OF THE SCREW AND THE WIRE WERE PROVIDED AND BASED ON THE OTHER RECEIVED INFORMATION IT IS IMPOSSIBLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE. WE CAN ONLY ASSUME THAT ANY EVENT DURING THE HEALING PROCESS, LIKE A FALL OR A JUMP, CAUSED THE BREAKAGE OF THE SCREW AND THE DEFORMATION OF THE WIRE. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A DOG WAS IMPLANTED WITH CORTEX SCREW AND K-WIRE FOR A CONDYLE HUMERAL FRACTURE ON (B)(6) 2012. IT WAS REPORTED THE SCREW BROKE AND THE WIRE BENT POST-OPERATIVELY. THE DOG WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. THE DOG WAS REVISED WITH PLATE AND SCREW CONSTRUCT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99683 CORTSCR Ø3.5 SELF-TAP L30 SST HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention