BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/14H/RIGHT/239MM

    MDR report key: 3133662 · Received May 29, 2013

    Report

    Report Number
    3003506883-2013-00237
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K013248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS TREATED WITH A FIBULA PLATE AND EXTERNAL FIXATION ON (B)(6) 2012. ON (B)(6) 2012, THE EXTERNAL FIXATION WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A TIBIA PLATE AND SCREWS. PATIENT WAS EXPERIENCING TIGHT SKIN DISTALLY. WHEN THE SURGEON LIFTED A PORTION OF THE SCAB HE NOTED THE PLATE WAS SHOWING THROUGH. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 AND THE SURGEON REMOVED THE TIBIA PLATE AND SCREWS. NO ADDITIONAL FIXATION WAS PLACED AS THE PATIENT WAS CONSIDERED HEALED. IT WAS REPORTED THAT THE EXPOSURE OF THE PLATE WAS DUE TO THE PATIENTS SOFT TISSUE REACTION TO THE PLATE. THERE WAS NO BACKING OUT OF THE SCREWS OR IMPLANT MIGRATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236028 3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/14H/RIGHT/239MM HRS SYNTHES ELMIRA 6378007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention