BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK

    MDR report key: 17450821 · Received August 3, 2023

    Report

    Report Number
    8030965-2023-09716
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    UDI-DI
    10887587023984
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: B3: ONLY THE EVENT YEAR IS KNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. D10: CONCOMITANT PRODUCTS ARE AS FOLLOWS: TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK (X3), 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM (X21), 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM (X8), TI MATRIX CURVED SAGITTAL SPLIT PLATE/6 HOLES/6MM BAR (X2), TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK (X3), 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM (X4), MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM (X1). H3, H4, H6: 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ORTHOGNATHIC SURGERY INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. IMAGING PERFORMED ON AN UNKNOWN DATE SHOWED UNSTABLE FIXATION AND MALOCCLUSION, SO A REVISION SURGERY IS PLANNED FOR THE NEAR FUTURE. THIS REPORT INVOLVES ONE TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 3 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699710 TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK PLATE, BONE JEY SYNTHES GMBH 10887587023984

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention