BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 4232193 · Received November 6, 2014

    Report

    Report Number
    2520274-2014-14553
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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): 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6), 2012 FOR PLACEMENT OF RECONSTRUCTIVE MANDIBULAR PLATE FOLLOWING A BONE FRACTURE. ON (B)(6), 2013 LOCAL INFECTION WAS DIAGNOSED AND THE PATIENT UNDERWENT MANDIBULAR OSTEOPLASTY TO REMOVE DAMAGED BONE AND REPLACE IMPLANTED PLATE WITH A NEW ONE. A POSITIVE OUTCOME WAS OBSERVED. THIS REPORT IS FOR AN UNKNOWN PLATE. (B)(4).

    Description of Event or Problem · 1

    PER ADDITONAL INFORMAITON RECEVIED PER AN INTERNAL REVIEW; IT WAS CONFIRMED THAT THERE IS A PLATE AS DESCRIBED IN THE COMPLAINT NARRATIVE. DUE TO THE MINIMAL INFORMATION AND CONSIDERING THE MULTIPLE CAUSES ASSOCIATED WITH A BROKEN PLATE AND THE ASSOCIATED PAIN. PERSISTENT PAIN IS A COMMON FINDING IN OLDER POPULATIONS AND OFTEN DEPENDS ON THE DEGREE OF INVASIVENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713367 BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention