BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM NARROW LCP® PLATE 8 HOLES/152MM

    MDR report key: 3584078 · Received January 21, 2014

    Report

    Report Number
    2520274-2014-00252
    Event Type
    Injury
    Date Received
    January 21, 2014
    Report Date
    August 14, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS AN UNKNOWN PLATE, QUANTITY 1. IMPLANT DATE IS (B)(6) 2011. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS PART NUMBER 224.581 MADE ON WORK ORDER (B)(4) AND LOT NUMBER 4982708 HAD NO NCRS. MATERIAL 4630669 FROM WHICH THESE PARTS WERE MADE HAD NO NCRS AND CERTIFICATES WERE FOUND TO BE IN ORDER. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    NOTICE OF CIVIL ACTION RECEIVED INDICATES ON (B)(6) 2011 PATIENT UNDERWENT A RIGHT KNEE PROCEDURE WHICH INCLUDED A MEDIAL OSTEOTOMY AND A PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH IMPLANTATION OF UNSPECIFIED SYNTHES AND COMPETITORS HARDWARE. AROUND (B)(6) 2011 PATIENT WAS WALKING DOWN STEPS AND HEARD AND FELT A CRACK AROUND HER RIGHT KNEE WHICH WAS SUBSEQUENTLY NOTED TO BE A RIGHT TIBIAL SHAFT FRACTURE BELOW THE OSTEOTOMY. ON (B)(6) 2011 THE SURGEON ADVISED PATIENT WOULD BE SCHEDULED FOR ANOTHER PROCEDURE. ON (B)(6) 2011, WHILE STILL ON CRUTCHES, THE PATIENT TRIPPED IN A HOLE AND/OR DITCH AND WAS SUBSEQUENTLY DIAGNOSED WITH A TIBIA AND FIBULA FRACTURE. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2011 FOR IMPLANTATION OF COMPETITORS SCREWS AND SYNTHES 4.5 MM PLATE ON HER TIBIA. DURING A FOLLOW-UP ON (B)(6) 2012 AN X-RAY SHOWED THE HARDWARE HAD FAILED. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE AND REVISION TO AN UNKNOWN NAIL. THIS REPORT IS ON AN UNKNOWN PLATE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    PATIENT WITH A PREVIOUS PATELLOFEMORAL LIGAMENT RECONSTRUCTION AND OPEN FULKERSON ANTERIOR MEDIAL OSTEOTOMY EXPERIENCED A TIBIA FRACTURE BELOW THE OSTEOTOMY. PATIENT WAS RETURNED TO THE OPERATING ROOM AND WAS IMPLANTED WITH AN 8 HOLE PLATE AND SIX SCREWS, THREE ABOVE THE FRACTURE AND THREE BELOW THE FRACTURE. ON (B)(6) 2012 THE PATIENT COMPLAINED OF INCREASED PAIN AND AN X-RAY NOTED THE PLATE WAS BROKEN AND A NONUNION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF ALL HARDWARE. ALL EIGHT SCREWS (SIX FROM THE PLATE AND TWO FROM THE OSTEOTOMY) WERE REMOVED INTACT. THE PATIENT WAS IMPLANTED WITH A TIBIA NAIL LOCKED DISTALLY WITH TWO INTERLOCKING SCREWS AND WAS LOCKED PROXIMALLY THROUGH THE DYNAMIC HOLE POSITION. PLACEMENT OF THE NAIL WAS CHECKED WITH FLUOROSCOPE AND INFUSE STRIPS WERE PLACED OVER THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50304 4.5MM NARROW LCP® PLATE 8 HOLES/152MM KTT SYNTHES ELMIRA 4982708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention