BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT

    MDR report key: 3894539 · Received June 25, 2014

    Report

    Report Number
    3003506883-2014-10063
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK120854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORD REVIEW (DHR): PART NUMBER 02.118.407 MADE ON WORK ORDER (B)(4) AND LOT NUMBER 7127694 HAD NO NONCONFORMANCE REPORTS (NCR). MATERIAL (B)(4), LOT # 7051621, FROM WHICH THESE PARTS WERE MADE HAD ONE NCR. NCR (B)(4) WAS WRITTEN TO ADDRESS A DOCUMENTATION ERROR ON THE C OF T. THE INCORRECT HEAT NUMBER WAS DOCUMENTED ON THE C OF T. DOCUMENTATION WAS REWORKED BY ADDING A CORRECTED C OF T TO THE DHR. THIS ERROR WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. CERTIFICATES WERE CORRECTED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WENT TO THE OPERATING ROOM FOR HARDWARE REMOVAL ON (B)(6) 2014 DUE TO PAIN ONLY, THE FRACTURE HAD HEALED. THE PATIENT COMPLAINED OF PAIN AT THE SURGICAL SITE AND WANTED THE HARDWARE THAT WAS IMPLANTED ON (B)(6) 2013 REMOVED FROM HER LEFT PROXIMAL LATERAL TIBIA AND FROM HER DISTAL FIBULA AND MEDIAL MALLEOLUS, ALL HARDWARE SUCCESSFULLY REMOVED. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371569 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 7127694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention