BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 24MM

    MDR report key: 3915767 · Received July 7, 2014

    Report

    Report Number
    2520274-2014-12382
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK131186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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

    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 IS EXPERIENCING PAIN AND POSSIBLE ALLERGIC REACTION DUE TO AN IMPLANT THAT OCCURRED. FOR ADDITIONAL INTERVENTION, A PRODUCT COMPOSITION WAS REQUESTED BY THE PARENT TO THE ALLERGY CENTER. THE ALLERGY CENTER REQUESTED ADDITIONAL INFORMATION FROM THE SYNTHES ENGINEERING DEPARTMENT, WHICH PROVIDED THE ALLERGY CENTER WITH THE CHEMICAL COMPOSITION OF THE MATERIALS THAT WERE IMPLANTED. THIS IS REPORT 9 OF 12 FOR (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE COMPLAINT RECEIVED STATES THAT POST IMPLANTATION THE PATIENT IS EXPERIENCING PAIN AND POSSIBLE ALLERGY SYMPTOMS. THE PATIENT IS HAVING ONGOING SHOULDER PAIN ON THE RIGHT SIDE AND WAS PREVIOUSLY IMPLANTED WITH A RIGHT SHOULDER PLATE SYSTEM. THE REQUEST FOR MATERIAL COMPOSITION HAS BEEN MADE; ALTHOUGH, THE PATIENT HAS SINCE TESTED NEGATIVE FOR METAL RELATED ALLERGIC REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393414 3.5MM CORTEX SCREW SELF-TAPPING 24MM PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention