BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PROXIMAL TIBIA PLATELOW BEND 10 HOLES/154MM/LEFT

    MDR report key: 3140681 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-02966
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K011978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THE LOT NUMBER COULD NOT BE VERIFIED WITH THE PART NUMBER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, LOT NUMBER COULD NOT BE VERIFIED WITH THE PART NUMBER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. INSPECTION PERFORMED DURING EVALUATION OF THE DEVICE, AGAINST THE INSPECTION REQUIREMENTS AT THE TIME THE PART WAS RELEASED, FOUND NO IRREGULARITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BECAME AWARE OF A PROBLEM ON (B)(6) 2013 AND PRESENTED TO THE SURGEON WITH A BROKEN PLATE ON (B)(6) 2013, ON WHICH DATE IT WAS EXPLANTED AND REVISED TO A NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE ORIGINAL INJURY WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242107 3.5MM LCP PROXIMAL TIBIA PLATELOW BEND 10 HOLES/154MM/LEFT HRS SYNTHES USA 6498124

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention