BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT

    MDR report key: 4939692 · Received July 24, 2015

    Report

    Report Number
    1000562954-2015-10153
    Event Type
    Injury
    Date Received
    July 24, 2015
    Report Date
    July 13, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT REPORTED AS (B)(6). ADDITIONAL PRODUCT CODES: HRS AND HWC. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: NOVEMBER 17, 2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2015. REMOVED HARDWARE INCLUDES A BROKEN 12-HOLE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) PLATE. THE PATIENT PRESENTED WITH FOUR DAYS OF WORSENING PAIN. THE PATIENT WAS REVISED TO A LONGER 16-HOLE PLATE. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2015, FOR A FRACTURED RIGHT PERIPROSTHETIC LEG. THERE WERE NO FRAGMENTS OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482758 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/RIGHT IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO 9247581

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention