BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STRAIGHT PLATE/8 HOLES

    MDR report key: 3997468 · Received August 10, 2014

    Report

    Report Number
    2520274-2014-12984
    Event Type
    Injury
    Date Received
    August 10, 2014
    Report Date
    February 21, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PK093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME: HWC, JDQ. 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 A PATIENT UNDERWENT A STERNAL CLOSURE PROCEDURE ON (B)(6) 2013. POST-OPERATIVELY, THE PATIENT EXPERIENCED DISCOMFORT AT THE BOTTOM OF THE STERNUM. ON (B)(6) 2014 TWO OF THE PLATES WERE REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THIS IS REPORT 1 OF 14 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474614 TI STERNAL LOCKING STRAIGHT PLATE/8 HOLES PLATE,FIXATION,BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention