BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI STERNAL LOCKING STAR PLATE-12 HOLES

    MDR report key: 4875570 · Received June 29, 2015

    Report

    Report Number
    2520274-2015-14678
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES: JDQ AND HWC. DEVICE NOT REPORTEDLY 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. H4: UNKNOWN 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 PLATE BROKE WHILE IT WAS BEING BENT ON THE BACK TABLE DURING A STERNAL CLOSURE FOR NON-UNION RESULTING FROM A COMPETITOR¿S DEVICE. DESPITE THE BREAK, THE PLATE WAS USED / IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR A TITANIUM STERNAL LOCKING PLATE 12 HOLE ¿ THE TOTAL IMPLANT INCLUDES THE PLATE AND ELEVEN (11) SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420068 TI STERNAL LOCKING STAR PLATE-12 HOLES PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1