BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM

    MDR report key: 10257716 · Received July 10, 2020

    Report

    Report Number
    8030965-2020-04765
    Event Type
    Injury
    Date Received
    July 10, 2020
    Report Date
    June 18, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H3, H6: DHR REVIEW FOR STERILIZATION ONLY: PART: 04.503.640.01S, LOT: L210584, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: NOVEMBER 28, 2016, EXPIRY DATE: NOVEMBER 01, 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NON STERILE PART: PART: 04.503.640.20 LOT: H162296, MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: AUGUST 06, 2016. PART: 04.503.640.20, 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM, LOT: H162296 (NON-STERILE). WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT DIMENSIONAL / FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART: 21015, TIALNBRI4.00 LOT: 9954218. CERTIFIED TEST REPORT SUPPLIED BY PERRYMAN COMPANY WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THAT ON (B)(6) 2018 THE PATIENT UNDERWENT RECONSTRUCTIVE SURGERY FOR LOWER JAW WITH THREE (3) SCREWS (PRODUCT CODE: 04.503.646.01S, LOT NUMBER: L997703) AND A PLATE. ON (B)(6) 2019, THE SURGEON CONFIRMED THAT THE SCREW HAD BEEN BROKEN THE THREE (3) SCREWS WERE REMOVED, LEAVING THE PLATE. ON (B)(6) 2020 THE SURGEON REMOVED THE PLATE DUE TO AN INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR (1) 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM. THIS IS REPORT 3 OF 6 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723497 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM BONE PLATE JEY OBERDORF SYNTHES PRODUKTIONS GMBH L210584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP| LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP| LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP| LOCK SCR Ø2.4 SELF-TAP L16 TAN 1U I/CLIP| TIPREMED RECON PL/MED/LT/2.5MM THK-ST