BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSTATIC BONE PUTTY-STERILE

    MDR report key: 2500093 · Received March 20, 2012

    Report

    Report Number
    1719045-2012-00163
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 22, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MTJ
    PMA / PMN Number
    K103822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THE DHR'S FOR (B)(4) WERE REVIEWED. NO NONCONFORMANCES WERE FOUND. SINCE IT IS STERILE, NO PHYSICAL EXAMINATION OF THE PRODUCT CAN OCCUR. THE PRODUCT PACKAGING INTEGRITY AND LABELS ARE VISUALLY VERIFIED AND WERE FOUND CONFORMING. THE STERILIZATION WAS VERIFIED AND FOUND CONFORMING. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFO THAT IS UNK, UNAVAILABLE OR UNCHANGED.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL DISC FUSION, THE SURGEON BACKFILLED THE HOLES LEFT BY HIS DISTRACTION PINS WITH HEMOSTATIC BONE PUTTY. THE PT EXPERIENCED AN ASPIRATION PNEUMONIA POSSIBLY RELATED TO ANESTHESIA PER THE REPORT. AT F/U SURGEON ALSO REPORTED THAT AS THE PT WAS HEALING, HE EXPERIENCED SWELLING THAT REQUIRED DRAINAGE AND RESULTED IN SOME DIFFICULTY SWALLOWING ON DAY 1 POST-OP. THE SITE WAS DRAINED ONCE MORE (FOR A TOTAL OF TWO TIMES), AND THE PT WAS DISCHARGED ON APPROX POST-OP DAY 3 OR 4. THE OPERATIVE SURGEON NOTED THE FOLLOWING; AMOUNT OF DRAINAGE ATYPICAL AND SEROSANGUINOUS IN NATURE, PT AFEBRILE, CT SCAN WAS PERFORMED AND SHOWED ABSENCE OF HEMATOMA, SIGNIFICANT SWELLING IN THE MUSCLES AND SOFT TISSUES PRESENT, AND IT WAS ALSO NOTED THAT THE LONGUS COLLI MUSCLES APPEARED TO BE SWOLLEN. SURGEON IS UNSURE AS TO SOURCE OF PT REACTION AT PRESENT. ACDF WAS PERFORMED WITH ALLOGRAFT SPACER FROM A LOCAL BONE BANK IN CONJUNCTION WITH A SYNTHES CERVICAL PLATE. NO OTHER PRODUCTS OR DEVICES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTATIC BONE PUTTY-STERILE HEMOSTATIC BONE PUTTY-STERILE MTJ SYNTHES MONUMENT 6711104

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention