BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

    MDR report key: 4939121 · Received July 24, 2015

    Report

    Report Number
    2520274-2015-15004
    Event Type
    Injury
    Date Received
    July 24, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 21MAY2013. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. ADDITIONAL PRODUCT CODES: JDP AND HWC. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED LOT NUMBER FOR THIS DEVICE COULD NOT BE VALIDATED FOR THE REPORTED PART NUMBER 222.656; HOWEVER, IT IS VALID FOR A SIMILAR PART, 02.124.406, 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT, 510(K) K110354, COMMON NAME PLATE, FIXATION, BONE, (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPORTER. DATE OF IMPLANT IS UNKNOWN BUT WAS REPORTED AS APPROXIMATELY TWO YEARS PRIOR TO (B)(6), 2015. WITHOUT A VALID LOT NUMBER FOR THE REPORTED PART NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. ADDITIONAL INFORMATION REGARDING THE PART NUMBER AND LOT NUMBER HAS BEEN REQUESTED. 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 REVISION SURGERY DUE TO NON-UNION OF A DISTAL FEMUR FRACTURE WAS PERFORMED ON (B)(6), 2015. THE ORIGINAL IMPLANT PROCEDURE OCCURRED APPROXIMATELY TWO YEARS AGO. ALL HARDWARE WAS REMOVED: A FULLY INTACT 4.5MILLIMETER (MM) LOCKING COMPRESSION PLATE CONDYLAR PLATE, FIVE INTACT 5.0MM CANNULATED LOCKING SCREWS AND FOUR 4.5MM CORTEX SCREWS, THREE OF WHICH WERE BROKEN. THE PATIENT WAS REVISED TO A DISTAL FEMUR PLATE AND SCREWS. THERE WERE NO REPORTED FRAGMENTS, SURGICAL DELAY OR MEDICAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482775 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT PLATE, FIXATION, BONE HRS SYNTHES MEZZOVICO 8437523

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention