BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM

    MDR report key: 10221106 · Received July 1, 2020

    Report

    Report Number
    8030965-2020-04608
    Event Type
    Injury
    Date Received
    July 1, 2020
    Report Date
    June 19, 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, H4, H6: 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. 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 · 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: 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 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 2 OF 6 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - SCREWS: CMF/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. INITIAL REPORTER OCCUPATION: REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE REMOVAL OF THE PLATE SURGERY ON (B)(6) 2020. THE PATIENT UNDERWENT RECONSTRUCTIVE SURGERY FOR LOWER JAW ON AN UNKNOWN DATE. AFTER THE SURGERY, HALF A YEAR AGO FROM NOW, THE SURGEON CONFIRMED THAT SCREW WAS BROKEN, AND INFECTION OCCURRED. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - SCREWS: CMF. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682179 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.| UNK - PLATES: CMF.