BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCP 2 6HO L32 SST

    MDR report key: 2895441 · Received January 3, 2013

    Report

    Report Number
    8030965-2013-00019
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXT
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4): THE PLATE IS BROKEN APART AT THE THIRD HOLE. THE RELEVANT DIMENSIONS OF THE HOLE, WHERE THE BREAKAGE OCCURRED, CAN NOT BE VERIFIED. THE MICROSCOPIC VIEW HAS SHOWN THAT THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A 2.0MM DCP 6-HOLE PLATE BROKE APPROXIMATELY 1 MONTH POST IMPLANT. PLATE WAS USED TO REPAIR A FRACTURE ON A DISTAL RADIUS/ULNA OF A (B)(6) CANINE TOY POODLE. POODLE WAS RETURNED TO THE O.R. FOR REMOVAL OF BROKEN PLATE. NO INFORMATION WAS PROVIDED REGARDING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648 DCP 2 6HO L32 SST DCP 2 6HO L32 SST LXT SYNTHES GMBH 1862077

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention