BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/10MM

    MDR report key: 3925265 · Received July 10, 2014

    Report

    Report Number
    2520274-2014-12487
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT REPORTED AS (B)(6). DATE OF EVENT: UNKNOWN. DEVICE HAS NOT BEEN EXPLANTED. 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 DURING A TRAUMA CASE BOTH STERNAL FIXATION AND RIB FIXATION WERE IMPLANTED ON (B)(6) 2014 AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY IN SURGERY. THE HOSPITAL REPORTED ON (B)(6) 2014 THAT ONE OF THE APPROXIMATELY TWENTY SCREWS IMPLANTED HAS DISLODGED OR HAS BACKED OUT. THE SURGEON WAS HAPPY WITH THE PATIENT PROGRESS AND FEELS NO NEED FOR RE-OPERATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403458 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/10MM PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1