BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING SCREW

    MDR report key: 12159008 · Received July 13, 2021

    Report

    Report Number
    2939274-2021-03834
    Event Type
    Injury
    Date Received
    July 13, 2021
    Report Date
    June 14, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MNI
    UDI-DI
    10705034739229
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODES: KWP, MNH, NKG. INITIAL REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS UNDERGOING CERVICAL FUSION. THIS REPORT CAPTURES THE FOLLOWING COMPLICATIONS: PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS (5): PATIENT NO (B)(6), FEMALE, (B)(6) WHO UNDERWENT REVISION POSTERIOR CERVICAL FUSION WAS READMITTED DUE TO PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THIS REPORT IS FOR A POSTERIOR CERVICAL SYSTEMS (SYNAPSE) LOCKING SCREW. THIS IS REPORT 2 OF 8 FOR (B)(4). ADDITIONAL COMPLICATIONS FOR THIS CER ARE CAPTURED ON RELATED COMPLAINTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057700 TI LOCKING SCREW ORTHOSIS, SPINAL PEDICLE FIXATION MNI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.614.508 10705034739229

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention