BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER

    MDR report key: 4253973 · Received November 17, 2014

    Report

    Report Number
    1000562954-2014-10203
    Event Type
    Injury
    Date Received
    November 17, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION, THUS, THE DOCUMENTS DETAILING THE STERILIZATION WERE NOT REVIEWED. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 THE SURGEON DID A REVISION ON (B)(6) 2014 ON A PATIENT THAT HAD A NONUNION OF A FEMUR FRACTURE. THE FRACTURE WAS PREVIOUSLY OPERATED ON AND PLATED WITH A 12 HOLE, 4.5MM VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) CURVED FEMUR PLATE AROUND (B)(6) OF 2013. THE SURGEON REMOVED THE 12 HOLE RIGHT VA-LCP CURVED FEMUR PLATE AND 13 SCREWS, (ELEVEN 5.0MM VARIABLE ANGLE SCREWS AND TWO 4.5 CORTEX SCREWS). THE PLATE HAD BROKEN JUST PROXIMAL TO THE CONDYLES AROUND THE FIRST AND SECOND HOLE IN THE SHAFT. NO SCREWS APPEARED TO BE BROKEN OR LOOSENED FROM THE PLATE. THEY FIXED THE NONUNION WITH A 14 HOLE RIGHT VA-LCP CURVED FEMUR PLATE. NO PAIN WAS REPORTED. THERE WERE NO ISSUES IN REMOVAL OF THE ORIGINAL PLATE AND THE REVISION WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM OR SURGICAL DELAY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742901 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER IMPLANT,FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO 8169995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention