BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® MEDIAL DISTAL TIBIAPLATE 4 HOLES/116MM-LEFT

    MDR report key: 2926407 · Received January 23, 2013

    Report

    Report Number
    8030965-2013-00196
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K013248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A 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

    PATIENT WAS IMPLANTED WITH PROXIMAL HUMERUS PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. IT IS REPORTED THAT AFTER VIEWING ROUTINE POST-OPERATIVE FOLLOW UP IMAGES, SURGEON STATED THAT HE WAS NOT HAPPY WITH THE REDUCTION OF THE FRACTURE. PATIENT RETURNED TO THE O.R. ON (B)(6) 2012, AND ALL HARDWARE WAS REMOVED. THIS IS 1 OF 13 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32343 3.5MM LCP® MEDIAL DISTAL TIBIAPLATE 4 HOLES/116MM-LEFT PLATE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention SCREWS