BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK

    MDR report key: 4180041 · Received October 17, 2014

    Report

    Report Number
    2520274-2014-14164
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK091233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.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

    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 SURGERY ON (B)(6) 2014 FOR A SUBCONDYLAR FRACTURE. IT WAS REPORTED THAT THE SURGEON CONTACTED THE SALES CONSULTANT TODAY AND UPON X-RAY, IT WAS IDENTIFIED THE SUBCONDYLAR PLATE BROKE. THE REVISION SURGERY IS PLANNED FOR (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT DID HAVE THE PLANNED EXPLANT SURGERY AND THE PLATE AS WELL AS SEVEN SCREWS WERE REMOVED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS AGAINST USER FACILITY MEDWACTH # (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662929 TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK PLATE, BONE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention