BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX SAGITL SPLIT PL STR/4 H/6 BAR

    MDR report key: 12672502 · Received October 21, 2021

    Report

    Report Number
    2939274-2021-06217
    Event Type
    Injury
    Date Received
    October 21, 2021
    Report Date
    September 27, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JEY
    UDI-DI
    10887587024370
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER IS A SYNTHES EMPLOYEE. (B)(4). THE TI MATRIX SAGITL SPLIT PL STR/4 H/6 BAR (P/N: 04.511.421, LOT NUMBER: L832999) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS NOTICED THAT THE PLATE WAS DEFORMED NEAR THE HOLES. ALSO, THE PLATE WAS OBSERVED TO BE BENT. ADDITIONALLY, IT WAS FOUND THAT THE PLATE WAS DISCOLORED AND HAD SCRATCHES. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. THE COMPLAINT CONDITION CAN BE CONFIRMED FOR TI MATRIX SAGITL SPLIT PL STR/4 H/6 BAR (P/N: 04.511.421, LOT NUMBER: L832999). THE DEFORMATION ON THE PLATE COULD HAVE CAUSED DUE TO THE STRESS APPLIED BEFORE THE CONSOLIDATION PHASE DUE TO USER NONCOMPLIANCE. THE DEFORMED CONDITION OF THE PLATE COULD HAVE CAUSED THE COMPLAINT CONDITION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART: 04.511.421-US, LOT: L832999, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 30 MARCH 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571651 TI MATRIX SAGITL SPLIT PL STR/4 H/6 BAR PLATE, BONE JEY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.511.421 L832999 10887587024370

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM| TI MATRIX SAGITL SPLIT PL STR/4 H/6 BAR