BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV

    MDR report key: 12643219 · Received October 15, 2021

    Report

    Report Number
    3003604053-2021-00252
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 23, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    ORQ
    UDI-DI
    00854501006005
    PMA / PMN Number
    K140300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FIVE MONTHS AFTER PROCEDURE USING REGENETEN, PATIENT WAS HAVING PAIN AND HYPER SYNOVITIS CHANGES. PLAN AT THIS TIME WAS TO GET INFECTION LABS AND SCHEDULE PATIENT FOR A SCOPE/WASH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536205 UNKN REGENETEN BIOINDUCTIVE IMPLANT SYSTEM DEV MESH, SURGICAL, DEPLOYER ORQ SMITH & NEPHEW, INC. 2169-2 UNK 00854501006005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other