BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4249728 · Received November 14, 2014

    Report

    Report Number
    2520274-2014-14724
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT: DATE UNKNOWN. ADDITIONAL PRODUCT CODES: HRS, HWC. IMPLANT AND EXPLANT DATES: UNKNOWN. WITHOUT A LOT 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. 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 PATIENT HAD X-RAYS PERFORMED ON (B)(6) 2014 WHICH REVEALED A NON-UNION OF THE RIGHT FEMUR AND A BROKEN 10 HOLE, VARIABLE ANGLE LOCKING CONDYLAR PLATE (VALCP). THE PLATE WAS BROKE BETWEEN THE SCREWS IN THE SHAFT AND DISTAL CLUSTER OF SCREWS ON THE HEAD OF THE PLATE. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE. THE PLATE WAS BROKEN AT A SCREW HOLE BUT THERE WAS NO SCREW IN THE HOLE. NO DEVICE ALLEGATION AGAINST ANY OF THE SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737917 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/RIGHT IMPLANT,FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention