BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 12 HOLES 163MM

    MDR report key: 3439625 · Received October 31, 2013

    Report

    Report Number
    3003506883-2013-00388
    Event Type
    Injury
    Date Received
    October 31, 2013
    Report Date
    October 2, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K082807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. OTHER NUMBER: SHOULD BE LOT NUMBER. USER FACILITY REPORT NUMBER REPORTED AS (B)(4). INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PART NUMBER 223.621 MADE ON WORK ORDER (B)(4) AND LOT NUMBER 4896703 HAD NO NCRS. MATERIAL (B)(4) FROM WHICH THESE PARTS WERE MADE HAD NO NCRS AND CERTIFICATES WERE FOUND TO BE IN ORDER. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    SEE ATTACHED USER FACILITY 3500A THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559692 3.5MM LCP PLATE 12 HOLES 163MM HRS SYNTHES ELMIRA 4896703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention