BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.85MM TI MATRIX SCREW SELF-TAPPING/5MM

    MDR report key: 8429120 · Received March 18, 2019

    Report

    Report Number
    8030965-2019-62023
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 22, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JEY
    UDI-DI
    07611819358126
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. UPDATED EVENT DESCRIPTION PROVIDED FOR REPORTING. REPORTERS STATE: WESTERN AUSTRALIA INVESTIGATION SUMMARY: THE SCREW DELIVERED FROM SYNTHES TO CUSTOMER (THROUGH MATERIALISE) ARE ALL DELIVERED IN AN UNSTERILE CONDITION. BASED ON THIS NO INVESTIGATION WILL BE DONE ON THOSE FROM SYNTHES SIDE. THE RECEIVED INFORMATION WAS FORWARDED TO THE MATERIALISE FOR INVESTIGATION, AS THEY WERE RESPONSIBLE FOR DEVELOPMENT OF PLATE AND SCREW CONNECTION, PLEASE FIND THE STATEMENT BELOW: RESULTS + DATE: (ME18-RAZ-PUX - C-MED-19-4202, PC-000398816 AND PC-000409327). FOR THIS COMPLAINT, THE DEVICE HISTORY RECORDS OF THE FIVE INFECTION CASES WERE REVIEWED. THE BSSO PLATES WERE DESIGNED ACCORDING TO THE WORK INSTRUCTIONS. AS SUCH, THE WORK INSTRUCTIONS ON SCREW PLACEMENT AND PLATE DESIGN WERE REVIEWED. IN THE APPLICABLE TIME FRAME, THE WORK INSTRUCTIONS WERE UPDATED TO ADJUST THE MAXIMUM DISTANCE BETWEEN THE SCREWS. AS THE MINIMUM SCREW DISTANCE REMAINED, THIS CHANGE WOULD NOT AFFECT THE ISSUE STATED BY THE COMPLAINANT. PROCESS CHANGES INITIATED IN THE APPROPRIATE TIME FRAME WERE EVALUATED. NO CHANGES AFFECTED THE BIOCOMPATIBILITY OR CLEANING PROCESS OF THE DEVICES. AS THE SURGEON INDICATED, SOME OF THE INFECTIONS PROBABLY OCCURRED DUE TO INADEQUATE WOUND CLOSURE. HOWEVER, THIS CANNOT BE CONFIRMED NOR EXCLUDED BASED ON THE AVAILABLE INFORMATION AND IT DOES NOT EXPLAIN THE OTHER INFECTION COMPLAINTS.. ROOT CAUSE PROCESS CATEGORY: ROOT CAUSE NOT FOUND FOR MORE INFORMATION SEE ATTACHED FINAL REPORT FROM MATERIALISE AT PC LEVEL. 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

    (B)(6) 2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A BILATERAL SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE USING A TRUMATCH MANDIBLE PLATE AND A TITANIUM MATRIX ORTHOGNATHIC SELF-TAPPING SCREWS. HOWEVER, ON (B)(6) 2019, THE PATIENT WAS PRESENTED WITH A POST-OPERATIVE INFECTION ASSOCIATED WITH THE MANDIBULAR PLATE ON BOTH SIDES WITH PUS FROM THE INCISION LINE. THERE IS A CONCERN ABOUT THE CLOSENESS OF THE POSTERIOR SCREWS TO EACH OTHER WHICH MAY INCREASE THE RISK OF BONE NECROSIS DUE TO A REDUCTION IN BLOOD SUPPLY. THERE IS ALSO A CONCERN ABOUT THE CLOSENESS OF THE PLATE TO THE BUCCAL INCISION MARGIN AS THIS MAY INCREASE THE RISK OF INFECTION. THE PATIENT WAS GIVEN WITH AN AMOXICILLIN AND FLAGYL FOR ANTIBIOTICS ON (B)(6) 2019, AND WAS CHECKED AGAIN ON (B)(6) 2019. THERE HAS BEEN NO CHANGE IN ANTIBIOTIC PROTOCOL, SUTURING TECHNIQUE OR IRRIGATION PROTOCOL AND IN THE CLEANING/STERILIZATION PROTOCOLS. THE PLATES WOULD BE REMOVED ONCE THE BONES ARE HEALED (AFTER 8 WEEKS). PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATED BY MFR, MANUFACTURE DATE, EVENT PROBLEM AND EVALUATION CODES: PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A BILATERAL SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE USING A TRUMATCH MANDIBLE PLATE AND A TITANIUM MATRIXORTHOGNATHIC SELF-TAPPING SCREWS. HOWEVER, ON (B)(6) 2019, THE PATIENT WAS PRESENTED WITH A POST-OPERATIVE INFECTION ASSOCIATED WITH THE MANDIBULAR PLATE ON BOTH SIDES. THERE IS A CONCERN ABOUT THE CLOSENESS OF THE POSTERIOR SCREWS TO EACH OTHER WHICH MAY INCREASE THE RISK OF BONE NECROSIS DUE TO A REDUCTION IN BLOOD SUPPLY. THERE IS ALSO A CONCERN ABOUT THE CLOSENESS OF THE PLATE TO THE BUCCAL INCISION MARGIN AS THIS MAY INCREASE THE RISK OF INFECTION. THE PATIENT WAS GIVEN WITH AN AMOXYCILLIN AND FLAGYL FOR ANTIBIOTICS AND WAS TO BE CHECKED AGAIN ON (B)(6) 2019. THERE HAS BEEN NO CHANGE IN ANTIBIOTIC PROTOCOL, SUTURING TECHNIQUE OR IRRIGATION PROTOCOL AND IN THE CLEANING/STERILIZATION PROTOCOLS. THERE ARE NO PLANS TO REMOVE THE IMPLANT AT THIS STAGE. THE PLATE CANNOT BE REMOVED AS TOO SOON AFTER SURGERY SO INFECTION NEEDS TO BE CONTROLLED WITH ANTIBIOTICS UNTIL BONY UNION OCCURS. PATIENT OUTCOME IS UNKNOWN. THIS (B)(4) CAPTURES 9-16 SCREWS WHILE (B)(4) IS THE INITIAL COMPLAINT THAT CAPTURES THE 1-8 SCREWS. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW. THIS IS REPORT 2 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223481 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM BONE PLATE JEY OBERDORF SYNTHES PRODUKTIONS GMBH 07611819358126

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention