BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 1/3-TUB-PL 3.5 5HO L64 TI

    MDR report key: 2893770 · Received January 2, 2013

    Report

    Report Number
    2520274-2013-00028
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ACCORDING TO THE REPORT, THE LOT NUMBER OF THE PLATE WAS REPORTED AS 442050. THIS LOT NUMBER IS UNKNOWN/INVALID AT SYNTHES (B)(4). WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH TI LCP ONE-THIRD TUBULAR PLATE AND FOUR SCREWS ON AN UNKNOWN DATE. PATIENT WAS RETURNED TO THE OR ON AN UNKNOWN DATE FOR PLANNED REMOVAL OF THE PLATE. DURING THE REMOVAL OF THE PLATE, TWO SCREWS WERE BLOCKED IN THE PLATE. A HSS DRILL BIT WAS USED TO DRILL OUT THE SCREW HEADS. THIS CAUSED DEBRIS AROUND THE LESION AND THE REMAINDERS OF THE SCREWS WERE LEFT IN THE PATIENT. THE DEVICES WERE DISPOSED OF BY THE ACCOUNT. NO SIGNIFICANT PROLONGATION OF THE OPERATION WAS CAUSED BY THIS OCCURRENCE. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818 LCP 1/3-TUB-PL 3.5 5HO L64 TI LCP ONE-THIRD TUBULAR PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, SCREW