BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 4H/RIGHT/86MM

    MDR report key: 3082356 · Received April 29, 2013

    Report

    Report Number
    3003506883-2013-00208
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K083213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. REVIEW OF THE RESPECTIVE RAW MATERIAL AND FINISHED PRODUCT DHR FILES FOUND NO IRREGULARITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS CONDITION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT ON THE RIGHT FIBULA ON (B)(6) 2013. IT WAS REPORTED THAT POST-OPERATIVELY, PATIENT HAD SKIN ISSUES AT THE INCISION SITE. THE SKIN WAS NOT HEALING WELL, BUT THE BONE HEALED PROPERLY. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS HEALED, SO THE SURGEON DID NOT REVISE PATIENT WITH ANY OTHER HARDWARE. IT WAS REPORTED THAT PATIENT DID NOT HAVE AN INFECTION AND NONE OF THE PARTS WERE BROKEN. THE SURGEON COMPLETED THE HARDWARE REMOVAL PROCEDURE WITHOUT ANY ISSUES. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184575 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 4H/RIGHT/86MM HRS SYNTHES ELMIRA 6926830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention