BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/LEFT/187MM

    MDR report key: 4093637 · Received September 16, 2014

    Report

    Report Number
    3003506883-2014-10107
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK013248
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 3.5MM LOW BEND MEDIAL DISTAL TIBIA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE 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-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO DEVICE WAS RETURNED FOR DIMENSIONAL INSPECTION. 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 SURGEON PERFORMED PLATING OF A DISTAL TIBIA FRACTURE ON (B)(6), 2014. UPON VIEWING AN X-RAY DURING A FOLLOW-UP VISIT THE MEDIAL DISTAL TIBIAL PLATE WAS FOUND TO BE BROKEN. IT WAS REPORTED THAT THE FRACTURE WAS IN A DELAYED HEALING NON-UNION/MALUNION STATE WHICH WAS NOTICED DURING SURGERY. A REVISION SURGERY WAS COMPLETED ON (B)(6), 2014 TO EXPLANT THE BROKEN PLATE AN UNKNOWN NUMBER OF INTACT SCREWS AND TWO BROKEN (3.5 LOCKING SCREWS) WERE REMOVED. NO FRAGMENTS WERE GENERATED FROM THE BROKEN PLATE AND SCREWS. PATIENT WAS REVISED WITH ONE (2.7/3.5) DISTAL TIBIAL PLATE THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY TIME DELAY. PATIENT STATUS/OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573330 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/LEFT/187MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 6218921

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention