BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES

    MDR report key: 3803312 · Received May 9, 2014

    Report

    Report Number
    2520274-2014-11385
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    PK010943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. THE PATIENT WAS ORIGINALLY TREATED FOR A STERNAL FRACTURE ON (B)(6) 2014. ON (B)(6) 2014 THE SURGEON WAS NOTIFIED BY THE HOSPITAL THAT THE PATIENT HAD AN INFECTION WITH PUS FORMING. ALL DEVICES WERE EXPLANTED ON (B)(6) 2014. THE SOURCE OF INFECTION IS UNKNOWN. A PECTORAL MUSCLE FLAP SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 8 OF 18 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280745 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES CERCLAGE FIXATION JDQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention