BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT

    MDR report key: 4946344 · Received July 28, 2015

    Report

    Report Number
    1000562954-2015-10156
    Event Type
    Injury
    Date Received
    July 28, 2015
    Report Date
    July 14, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS PERFORMED: THE FOLLOWING DEVICE WAS RECEIVED: 4.5MM VA-LCP CURVED CONDYLAR PLATE (PART # 02.124.411 / LOT # 8823150). THE PLATE IS BROKEN INTO TWO PIECES AT THE FIFTH COMBI HOLE FROM THE CONDYLAR HEAD OF THE PLATE. PER THE COMPLAINT DESCRIPTION A NON-UNION WAS PRESENT. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, IT IS LIKELY THAT EXCESSIVE LOADING DUE TO THE NON-UNION CAUSED THE COMPLAINT CONDITION. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. DRAWINGS FOR THE DEVICE WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGNS ARE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DEVICE PRIMARY CODE: JDP. [ADDITIONAL PRODUCT CODES: HRS, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF IMPLANT WAS NOT PROVIDED BY REPORTER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 PATIENT UNDERWENT HARDWARE REMOVAL OF A 4.5 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE, SEVEN 5.0 MM VARIABLE ANGLE LOCKING SCREWS AND ONE 4.5 MM CORTEX SCREWS, DUE TO NON-UNION OF THE LEFT DISTAL FEMUR AND A BROKEN PLATE. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488931 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO 8823150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention