BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2339532 · Received November 16, 2011

    Report

    Report Number
    1030489-2011-01504
    Event Type
    Injury
    Date Received
    November 16, 2011
    Date of Event
    October 9, 2011
    Report Date
    January 27, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7510600, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4).THIS PRODUCT IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7510600, PMA# P000054 WAS CLEARED IN THE UNITED STATES. MULTIPLE PRODUCTS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE PRODUCT 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PRODUCT HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN ACUTE TIBIA FRACTURE WITH EXTERNAL FIXATION USING RHBMP-2/ACS. INITIALLY, THE PATIENT DID WELL POST-OP. ON THE FIFTH DAY POST-OP, THE PATIENT DEVELOPED A MEDICALLY SIGNIFICANT TUMEFACTION AND AS INDICATED BY THE DOCTOR "TRANSPARENT LIQUID SUPPURATION" WITHOUT INFECTION, IT WAS SUCH A GREAT TUMEFACTION THAT THE SUTURES WERE COMPROMISED. THE PATIENT HAD NO FEVER. THE INFLAMMATION AND EDEMA STARTED TO GO DOWN THE 10TH DAY AND THE PATIENT HAD IMPROVED BUT WAS STILL UNDER MEDICAL CONTROL IN THE HOSPITAL. THERAPEUTIC MEASURES TAKEN IN RESPONSE TO THE EVENT WERE NOT REPORTED. THE EVENT RESOLVED ON THE 29TH DAY POST-OP. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN ACUTE TIBIA FRACTURE WITH EXTERNAL FIXATION USING RHBMP-2/ACS. INITIALLY, THE PATIENT DID WELL POST-OP. APPROXIMATELY ON THE FOURTH OR FIFTH DAY POST-OP, THE PATIENT DEVELOPED SWELLING AT THE SURGICAL SITE, INDICATED BY THE DOCTOR AS "TRANSPARENT LIQUID SUPPURATION." THE SWELLING COMPROMISED THE SUTURES. NO INFECTION WAS NOTED. THE PATIENT HAD NO FEVER. THIS INFLAMMATION AND EDEMA STARTED TO GO DOWN THE 10TH DAY. THE PATIENT HAS IMPROVED BUT IS STILL UNDER MEDICAL CARE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK F35309

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention