BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSITCP 60 INTERFERENCE SCREW - D 10- L:30 MM; "FULLY THREADED"

    MDR report key: 10835491 · Received November 13, 2020

    Report

    Report Number
    3004549189-2020-00021
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    December 13, 2017
    Report Date
    November 12, 2020
    Manufacturer
    S.B.M. SAS
    Product Code
    HWC
    PMA / PMN Number
    K070507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIMILAR EVENTS EMERGE FROM THE SAME CLINICAL STUDY: COMPLAINTS FNC (B)(4) (FDA NUMBER 3004549189-2020-00009) AND FNC (B)(4) (FDA NUMBER 3004549189-2020-00008) ARE LINKED. PRODUCTS CONCERNED IN THIS EVENT: TIBIAL FIXATION MODE: SCREW / COMPOSITCP LOT 163238 ; REFERENCE NUMBER: 905261. THIS IS A SBM PRODUCT. NO OTHER COMPLAINT ABOUT THIS LOT NUMBER. FEMORAL FIXATION MODE: SCREW LACTOSORB ; REFERENCE NUMBER: 930600. THIS IS NOT A SBM PRODUCT. HISTORICAL: DATE OF INCIDENT: (B)(6) 2017 / RUPTURE LCA / SIDE LEFT. PRIMARY SURGERY: LIGAMENT PLASTY UNDER KNEE ARTHROSCOPY (B)(6) 2017 - NO COMPLICATIONS NOTED. DATE OF EVENT: (B)(6) 2017 / CYCLOPE / SIDE LEFT. DESCRIPTION OF SYMPTOMS: EXTENSION DEFICIT (MODERATE SEVERITY). TREATMENT: KNEE ARTHROSCOPY ON (B)(6) 2017 (RESOLUTION DATE). ACCORDING TO THE INFORMATION PROVIDED IN THE DATABASE OF THE SURGEON: NO LINK WITH THE DEVICE ; NO LINK WITH THE PROCEDURE ; NO LINK WITH THE INSTRUMENT. NO CORRECTIVE ACTION IMPLEMENTED. THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    FNC (B)(4). EVENT / CLINICAL PROJECT.: "IT WAS REPORTED THE PATIENT UNDERWENT A L ACL RUPTURE REPAIR ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT WAS NOTED TO HAVE CYCLOPE SYNDROME AND EXTENSION DEFICIT THAT WAS NOTED TO BE RESOLVED ON (B)(6) 2017 WITH ARTHROLYSIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299372 COMPOSITCP 60 INTERFERENCE SCREW - D 10- L:30 MM; "FULLY THREADED" INTERFERENCE SCREW HWC S.B.M. SAS 163238

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCREW LACTOSORB REF : 930600 (NOT SBM PRODUCT).