BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR

    MDR report key: 12319976 · Received August 13, 2021

    Report

    Report Number
    2939274-2021-04660
    Event Type
    Injury
    Date Received
    August 13, 2021
    Report Date
    July 16, 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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6- 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: MEZZOVICO. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. (B)(4). 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 · 1

    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. THIS IS REPORT 9 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218929 TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR PLATE, BONE JEY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.511.421 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| 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