BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/18MM

    MDR report key: 8495425 · Received April 9, 2019

    Report

    Report Number
    8030965-2019-62585
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    March 20, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819354135
    PMA / PMN Number
    K161590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. TWO (2) MATRIXRIB STERNAL PLATES (04.501.069 LOT L634021 AND L914845), SEVEN (7) LOCKING SCREWS DAMAGED (PART/LOT UNKNOWN), AND NINE (9) LOCKING SCREWS INTACT (PART/LOT UNKNOWN) WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION: THE VISUAL INSPECTION FOUND NO PRODUCT ISSUES THAT COULD HAVE CONTRIBUTED TO THE CLINICAL FINDING (INFECTION). SUMMARY: THIS COMPLAINT WAS ENTERED TO CAPTURE THE REVISION SURGERY DUE TO INFECTION. NO PRODUCT ISSUES THAT COULD HAVE CONTRIBUTED TO THIS CLINICAL FINDING WERE FOUND. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. THE DEVICE WAS RECEIVED, AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(4). 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 INITIALLY, THE PATIENT WAS IMPLANTED WITH MATRIXRIB STERNAL PLATES AND MATRIXRIB LOCKING SCREWS ON AN UNKNOWN DATE. ON (B)(6) 2019, AN OSTEOSYNTHESIS METAL REMOVAL WAS PERFORMED DUE TO AN INFECTION. THE DEVICES WERE SUCCESSFULLY REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS (B)(4) CAPTURES EIGHT (8) DEVICES AND LINKED (B)(4) CAPTURES ADDITIONAL TEN (10) DEVICES. THIS REPORT IS FOR ONE (1) MATRIXRIB LOCKING SCREW. THIS IS REPORT 2 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290079 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/18MM PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 07611819354135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention