BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2289024 · Received October 12, 2011

    Report

    Report Number
    1030489-2011-01321
    Event Type
    Injury
    Date Received
    October 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: SCHUCKERT ET AL. BONE TISSUE ENGINEERING IN ORAL SURGERY: A NEW METHOD OF BONE DEVELOPMENT IN PERIODONTAL SURGERY. TISSUE ENGINEERING 2011: VOL 17; NO 12. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510400, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4) - INSUFFICIENT BONE GROWTH. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510400, PMA # P050053 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT 20 PATIENTS UNDERWENT SURGICAL TREATMENT FOR PERIODONTAL BONE DEFECTS USING RHBMP-2/ACS. GROUP ONE CONSISTED OF EIGHT PATIENTS (3 FEMALE, 5 MALE, WITH 18 PERIODONTAL DEFECTS WITHOUT BONY WALLS). GROUP ONE WAS TREATED WITH THE MUCO-PERIOSTEAL FLAP TECHNIQUE USING RHBMP-2/ACS AND PLATELET-RICH PLASMA (PRP). GROUP TWO CONSISTED OF FIVE PATIENTS (1 FEMALE, 4 MALE, WITH 11 PERIODONTAL DEFECTS WITHOUT BONY WALLS). GROUP TWO WAS TREATED WITH AN ENDOSCOPIC BRIDGE-FLAP TECHNIQUE USING DBM, RHBMP-2 AND PREPARED PRP. GROUP THREE (CONSISTING OF 7 PATIENTS, 5 FEMALE AND 2 MALE WITH 16 PERIODONTAL DEFECTS) WAS TREATED WITH AN ENDOSCOPIC BRIDGE-FLAP TECHNIQUE USING TRICALCIUMPHOSPHATE, RHBMP-2 AND PREPARED PRP. ONE PATIENT IN GROUP TWO HAD A WOUND DEALING DEFECT ON ONE PERIODONTAL DEFECT. IN THIS DEFECT, NO BONE DEVELOPMENT COULD BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention