BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSITCP INTERFERENCE SCREW

    MDR report key: 6709768 · Received July 13, 2017

    Report

    Report Number
    3004549189-2017-00001
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    February 21, 2017
    Report Date
    June 8, 2017
    Manufacturer
    SBM SAS
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSMISSION DELAY / FOR REGULATION AFTER CONNECTION PROBLEM. CONCLUSION OF EXPERTISE REPORT - 8 JUNE 2017: (B)(4) / BATCH NO. 143957: NO OBSERVATION WAS POSSIBLE AS THE SCREW WAS NOT RETURNED TO S.B.M. POST-MANUFACTURING DATA ANALYSIS OF THE DAMAGED SCREW: THIS BATCH OF SCREWS PRESENTS NO MANUFACTURING DEFECT. EVERYTHING CONFORMS TO SPECIFICATIONS. THE MOLECULAR WEIGHT WAS HIGH, WHICH IS INDICATIVE OF GOOD MANUFACTURING CONDITIONS.

    Description of Event or Problem · 1

    (B)(4). EVENT OCCUR IN (B)(6) USA: "IT IS REPORTED THE PATIENT INITIALLY UNDERWENT ARTHROSCOPICALLY ASSISTED ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, RIGHT KNEE ON (B)(6) 2015. 1ST REVISION: ON (B)(6) 2015 PATIENT WAS REVISED DUE TO PAIN AND SWELLING IN THE RIGHT KNEE. PATIENT UNDERWENT ARTHROSCOPY RIGHT KNEE WITH MAJOR SYNOVECTOMY. REMOVAL DEEP HARD WARE, PROXIMAL TIBIA. REMOVAL DEEP HARD WARE, RIGHT LATERAL DISTAL FEMUR. 2ND REVISION: (B)(6) 2017 DUE TO PAINFUL RIGHT KNEE AND STATUS POST ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION IN RIGHT KNEE WITH AN EZI.OC ON THE FEMUR AND A BIOMET BIOCOMPOSITE SCREW ON THE TIBIA AS WELL AS AN ARTHREX STABLE. THIS COMPLAINT IS TO REPORT THE SECOND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493622 COMPOSITCP INTERFERENCE SCREW FIXATION SCREW, BONE BIODEGRADABLE MAI SBM SAS 905262 143957

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female