BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    SURGICAL SPECIALTIES

    MDR report key: 11676332 · Received April 15, 2021

    Report

    Report Number
    3010692967-2021-00013
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    February 13, 2021
    Report Date
    April 15, 2021
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    MTJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD, MANUFACTURING RECORDS, STERILITY RECORDS, INCOMING INSPECTION OF RAW MATERIAL COMPONENTS, IN-PROCESS AND FINAL INSPECTION PROCESS. NO NON-CONFORMITIES WERE IDENTIFIED. NO CHANGES WERE MADE TO THE FORMULATION, PROCESSES OR PACKAGING.THE PRODUCT IS SOLD TO CARDINAL HEALTH AS A STERILE PRODUCT, BULK DEVICE. NO PHOTOS WERE PROVIDED OF THE SURGICAL SITE OR OF THE DEVICE USED. NO STERILE DEVICES FROM LOT AAFU786 WERE RETURNED FOR TESTING/REVIEW. ACCORDING TO IFU P/N: 03-5125 R5 FOR BONE WAX 903B: UNDER ¿DIRECTIONS AND DOSAGE¿ SECTION: USE BONE WAX IMMEDIATELY AFTER REMOVAL FROM THE PACKAGE. USING ASEPTIC TECHNIQUE, TAKE 1 TO 1.5 GRAMS OF BONE WAX, MANIPULATE WITH THE FINGERS TO SOFTEN, AND APPLY TO BONE SURFACE. OPTIMUM WORKING TEMPERATURE 70°- 74° F ( 21°- 23°C). UNDER ¿STORAGE¿ SECTION: RECOMMENDED STORAGE CONDITIONS: BELOW 77° F (25 °C), AWAY FROM MOISTURE AND DIRECT HEAT. SAMPLES FROM A DIFFERENT LOT REPORTED FOR A SIMILAR ADVERSE CASE (AAGI410) WERE RECEIVED FROM THE FACILITY FOR REVIEW/TESTING. THE STERILE SAMPLES WERE MANIPULATED PER THE INSTRUCTIONS IN THE IFU. THE WAX BECAME WARM, MALLEABLE AND EASILY ADHERED TO A HARD SURFACE. THE WAX DEVICE WAS SIMILAR TO PUTTY, NO SIGNS OF FLAKES OR CRUMBLING WAS OBSERVED. WITHOUT RECEIVING ADDITIONAL DETAILS REGARDING THE PATIENT'S HEALTH HISTORY, PROCEDURE PERFORMED, METHOD UTILIZED TO MANIPULATE AND UTILIZE THE BONE WAX AND/OR THE SURGEON'S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT HAD INITIAL SURGERY ON (B)(6) 2020 WHERE BONE WAX WAS USED TO REPAIR THE CSF LEAK. PATIENT CAME BACK FOR SURGERY ON (B)(6) 2020 TO REPAIR CSF LEAK WITH THE BONE WAX. ONE OF AHS SITE IS HAVING ISSUE WITH BONE WAX CONTAINED IN CRANIOTOMY PACK. THERE HAVE BEEN ADVERSE INCIDENTS/PATIENT IMPACT RESULTING FROM USING THE BONE WAX. THE BONE WAX WAS IDENTIFIED AS BEING FLAKY. CARDINAL HEALTH CASE-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566911 SURGICAL SPECIALTIES BONE WAX MTJ SURGICAL SPECIALTIES CORPORATION 903B AAFU786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention