BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/45MM

    MDR report key: 6973999 · Received October 24, 2017

    Report

    Report Number
    3003506883-2017-10246
    Event Type
    Injury
    Date Received
    October 24, 2017
    Report Date
    October 8, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    UDI-DI
    10886982166838
    PMA / PMN Number
    K011335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTER WAS (B)(6) INCHES. ADDITIONAL PATIENT ID: (B)(6). DATE OF EVENT IS UNKNOWN. DATE OF IMPLANT IS UNKNOWN DATE APPROXIMATELY 15 YEARS PRIOR TO THE DATE OF REVISION ON (B)(6) 2017. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 241.341, LOT# 7823301. MANUFACTURING LOCATION:(B)(4). MANUFACTURING DATE: OCT 14, 2014. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE (DHR) SHOWS THIS LOT OF LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/45MM (PART NUMBER 241.341, LOT NUMBER 7823301) WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 UNDERWENT REVISION OF A LEFT SIDE ANKLE FUSION ON (B)(6) 2017 DUE TO MALUNION. TWO PLATES AND SIX SCREWS WERE ORIGINALLY IMPLANTED APPROXIMATELY 15 YEARS AGO. THE FUSION HEALED IN MALREDUCTION. THE PLATE AND SCREWS WERE REMOVED INTACT, AN OSTEOTOMY PERFORMED, THE DEFORMITY CORRECTED, AND THE ANKLE REFUSED. TWO NEW PLATES AND CORTEX SCREWS WERE IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES. THIS IS REPORT 2 OF 8 FOR (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753555 LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/45MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 241.341 7823301 10886982166838

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention