BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/12MM

    MDR report key: 3951421 · Received July 22, 2014

    Report

    Report Number
    2520274-2014-12777
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK133616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGEON VISIT THE PATIENT PRESENTED WITH PULMONARY PAIN DUE TO A HERNIATED LUNG. IN THE COURSE OF SURGERY ON (B)(6) 2014 TO ADDRESS THE HERNIATED LUNG ISSUE THE SURGEON NOTED THAT THE PATIENT HAD A MATRIX RIB PLATE AND 6 SCREWS FROM A PREVIOUSLY SURGERY TO ADDRESS A RIB FRACTURE. ORIGINAL SURGERY DATE AND DOCTOR ARE UNKNOWN. THE SURGEON REPORTED THAT 3 OF THE 6 SCREWS THAT WERE ORIGINALLY IMPLANTED WERE OUT OF THE RIB, THE ORIGINAL MATRIX PLATE AND OTHER 3 SCREWS WERE IN TACK WITH NO PROBLEMS. THE SURGEON REVISED THE PATIENT TO A LUNG PATCH AND NEW MATRIX PLATE AND SCREWS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY; THE PATIENT OUTCOME WAS REPORTED TO BE GOOD. THIS REPORT IS FOR 1 OF THE 3 SCREWS REPORTED TO HAVE DISLODGED FROM THE RIB. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428972 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/12MM PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention