BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD 16HO L296 SST

    MDR report key: 3230009 · Received July 16, 2013

    Report

    Report Number
    8030965-2013-04301
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K082807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT BECAUSE OF THE RESULTS OF OUR MACROSCOPIC INVESTIGATIONS WE ASSUME THAT THE LCP WAS SUBJECTED TO HIGH DYNAMIC LOADS IN A FIRST STATE (PLASTIC DEFORMATIONS, STRONGLY BENT). HOWEVER, BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES OF BOTH IMPLANTS (GREAT AREAS OF FATIGUE STRIATIONS) WE CAN CONCLUDE THAT FURTHERMORE THE IMPLANTS WERE SUBJECTED TO LOW OR MODERATE DYNAMIC BENDING LOADS (TWO-SIDED). THE IMPLANTS COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD /FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS FOR BOTH IMPLANTS CAN BE EXCLUDED. ADDITIONAL CODE: HWC. CORRECTED 510K AND PRODUCT CODE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS TREATED FOR A FRACTURE OF THE FEMORAL DIAPHYSIS. A PLATE HAD BEEN IMPLANTED ON (B)(6) 2013, AND DURING A VISIT ON (B)(6) 2013, THE PLATE WAS FOUND TO BE FRACTURED. THE PLATE COULD NOT BE REMOVED DUE TO HEALTH COMPLICATIONS SUSTAINED BY THE PATIENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328680 LCP 4.5/5 BROAD 16HO L296 SST HRS SYNTHES GMBH 2539345

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention