BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

    MDR report key: 3760329 · Received April 20, 2014

    Report

    Report Number
    2520274-2014-10970
    Event Type
    Injury
    Date Received
    April 20, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    PK022012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO EPILEPSY WITH BILATERAL FRONTAL CICATRICIAL GYRUS. THE SURGEON PERFORMED A RESECTION ON (B)(6) 2013 (6 PLATES AND 24 SCREWS WERE USED). ON (B)(6) 2014, THE INCISION RUPTURED WITH INFILTRATION. THE DRESSING WAS CHANGED, IT WAS NOTED THE CONDITION WAS NOT IMPROVED AND WORSENED EFFUSION WAS NOTED FROM THE SUBCUTANEOUS. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR DEBRIDEMENT AND REMOVAL OF THE IMPLANTS. THE SURGEON NOTED THE RUPTURE POSITION WAS CLOSE TO THE LOCATION OF THE IMPLANTED PLATES AND LIQUEFACTION WAS PRESENT FROM SUBCUTANEOUS TISSUE. THE SURGEON REMOVED ALL THE IMPLANTED PRODUCT, THE WOUND WAS REPORTED TO HAVE HEALED WELL. ON (B)(6) 2014, THE PATIENT HAD THE SAME PROBLEM. THE SURGEON SUSPECTED THE PATIENT HAD AN INFECTION DUE TO EITHER THE DECONTAMINATION ISSUE OR THE PATIENT¿S REJECTION REACTION TO THE PRODUCTS. AT THE TIME OF THIS REPORTED EVENT THE PATIENT WAS REPORTED TO BE IN A COMA. THIS IS REPORT 24 OF 30 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239163 TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention