BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN -TITANIUM STERNAL FIXATION SYSTEM

    MDR report key: 4586747 · Received March 10, 2015

    Report

    Report Number
    2520274-2015-11616
    Event Type
    Injury
    Date Received
    March 10, 2015
    Date of Event
    September 3, 2006
    Report Date
    February 21, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: SEPTEMBER 3, 2006. THIS REPORT IS FOR AN UNKNOWN TITANIUM STERNAL FIXATION SYSTEM, UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿RIGID FIXATION OF THE STERNUM USING A NEW COUPLED TITANIUM TRANSVERSE PLATE FIXATION SYSTEM.¿ (JUNE 2007) HALLOCK, G. G. AND SZYDLOWSKI, G.W ANNALS OF PLASTIC SURGERY 58; NUMBER 6, 640-644. A NEW TITANIUM STERNAL FIXATION SYSTEM THAT PERMITS TRANSVERSE ORIENTATION OF PLATES HAS BEEN USED IN 4 PATIENTS WHO HAD STERILE COMPLETE OR IMMINENT STERNAL DEHISCENCE TO ALLOW EVENTUAL STERNAL UNION. IN ALL FOUR PATIENTS STERNAL UNION WAS EVENTUALLY ACHIEVED USING THE TITANIUM STERNAL FIXATION SYSTEM (SYNTHES (B)(4)). ONE MORBIDLY OBESE MALE PLATED WITH THREE TRANSVERSE PLUS MANUBRIUM PLATES EXPERIENCED AN OPENED PINHOLE TRACT IN THE MIDSTERNUM WITH A PURULENT DISCHARGE THAT WAS IDENTIFIED AS A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. ANTIBIOTICS WERE ADMINISTERED. A CHEST X-RAY SUGGESTED STERNAL UNION WHICH WAS CONFIRMED WHEN A SINGLE INFECTED PLATE WAS REMOVED. THE OTHER PLATES WERE ALSO REMOVED AS A PROPHYLACTIC MEASURE BECAUSE THEY WERE NOT LONGER NEEDED WITHOUT EVIDENCE OF INFECTION. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TITANIUM STERNAL FIXATION SYSTEM. THIS REPORT IS FOR ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165681 UNKNOWN -TITANIUM STERNAL FIXATION SYSTEM PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention