BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNERSTONE HSR

    MDR report key: 896629 · Received July 13, 2007

    Report

    Report Number
    2031733-2007-00004
    Event Type
    Injury
    Date Received
    July 13, 2007
    Report Date
    July 17, 2007
    Manufacturer
    MACROPORE BIOSURGERY
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    1) NO CATALOG OR LOT NUMBERS WERE PROVIDED, AND THEREFORE, NO LOT HISTORY REVIEW COULD BE CONDUCTED. 2) THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THEREFORE, IT IS NOT POSSIBLE TO ASSESS WHETHER ANY MATERIAL OR MANUFACTURING DEFECTS WERE PRESENT IN THE IMPLANT. 3) AS POINTED OUT IN THE ARTICLE, BMP USE IN CERVICAL SPINE IS CURRENTLY NOT FOOD AND DRUG ADMINISTRATION APPROVED, AND HAS ONLY LIMITED HUMAN EXPERIENCE IN CERVICAL SPINAL SURGERY. 4) THE ARTICLE REPORTS SEVERAL STUDIES INVOLVING POST-OPERATIVE HEMATOMA AND RETROPHARYNGEAL SWELLING IN CASES OF BMP USE. 5) INSTRUCTIONS FOR USE ALSO CONTAIN THE WARNING "WHILE RARE, IMPLANTATION OF FOREIGN MATERIALS CAN RESULT IN AN INFLAMMATORY RESPONSE OR ALLERGIC REACTION." 6) ALTHOUGH THE IMPLANT WAS PRESENT DURING THE SURGICAL PROCEDURE, THERE IS NO EVIDENCE OR REPORT TO INDICATE THAT THE IMPLANT FAILED OR THAT THE IMPLANT WAS DIRECTLY RELATED TO THE ADVERSE EVENT. 7) THE ARTICLE CONCLUDES, "...IT IS UNLIKELY THAT THIS CASE REPRESENTS AN INFLAMMATORY RESPONSE SECONDARY TO THIS (PLA) DEGRADATION."

    Description of Event or Problem · 1

    "IMPLANT DATE UNK. MALE, WEIGHT: UNK. IT WAS REPORTED IN PERRI B ET AL (THE SPINE JOURNAL 7 (2007) 235-239) THAT A PT WHO HAD UNDERGONE A 2-LEVEL ACDF AT C3-C5 USING RHBMP-2/ACS AND CORNERSTONE HSR BIOABSORBABLE INTERBODY SPACERS SUPPLEMENTED WITH 48MM BLACKSTONE LOCKING PLATE AND 6 SCREWS BEGAN NOTICING INCREASED CERVICAL SWELLING ON POSTOPERATIVE DAY 3 THAT PROGRESSIVELY WORSENED OVER THE NEXT 3 DAYS. THE PT WAS TREATED IN THE EMERGENCY DEPT. ON POST-OP DAY 5 FOR ANTERIOR NECK SWELLING AND DYSPHAGIA. IN THE ED, "MASSIVE" NECK SWELLING WAS NOTED PRIMARILY IPSILATERAL TO THE SURGICAL APPROACH. CT SCAN TAKEN ON ADMISSION SHOWED TRACHEAL DEVIATION, RIGHT-SIDED SOFT TISSUE SWELLING OF THE NECK AND GAS WITHIN THE TISSUES WAS OBSERVED AT LEVELS BOTH ABOVE AND BELOW THE HYOID. A SURGICAL INTERVENTION WAS THEN PERFORMED FOLLOWING INTUBATION TO RE-OPEN THE SURGICAL WOUND AND DRAIN APPROX. 15ML OF SEROUS FLUID. NO DISCRETE HEMATOMA, ACTIVELY BLEEDING VESSELS OR PUS WAS OBSERVED. THE WOUND WAS IRRIGATED COPIOUSLY PRIOR TO CLOSURE. THE PT. WAS TREATED WITH TAPERING DOSE OF IV DECADRON AND WAS TRANSFERRED TO ICU FOR RECOVERY. THE PT WAS EXTUBATED 24 HOURS POST-OP AND EXPERIENCED GRADUAL IMPROVEMENT IN SWALLOWING AND RESOLUTION OF SWELLING. THE PT WAS DISCHARGED ON POST-OP DAY THREE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORNERSTONE HSR NONE FTL MACROPORE BIOSURGERY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening WITHIN THE RESORBABLE IMPLANT| RH-BMP-2 (RECOMBINANT BONE MORPHOGENETIC PROTEIN-2