BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PAED-HIPPL5 120° W/23 L95

    MDR report key: 2942128 · Received February 4, 2013

    Report

    Report Number
    8030965-2013-00294
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K112085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT UNDERWENT ROTATIONAL OSTEOTOMY OF THE PROXIMAL FEMUR. AFTER FOUR WEEKS, POST OPERATIVELY, PATIENT WALKED WITHOUT MEDICAL AUTHORIZATION. THIS WAS FOLLOWED BY THE LCP PAED-HIPPL5 BREAKING AND DELAYED CONSOLIDATION. THE EXPLANT DATE IS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46958 LCP PAED-HIPPL5 120° W/23 L95 LCP PAED-HIPPL5 HRS SYNTHES GMBH 7706267

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR