BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8495437 · Received April 9, 2019

    Report

    Report Number
    8030965-2019-62598
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    March 20, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. INVESTIGATION SUMMARY 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. INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: 7. ADVERSE EVENT (NO REPORTED PRODUCT PROBLEM). 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. (B)(4) AND (B)(4) CAPTURE THE OSTEOSYNTHESIS METAL REMOVAL DUE TO AN INFECTION WHILE (B)(4) CAPTURES THE INTRA-OP EVENTS WHERE THE DEVICES INVOLVED COULD NOT BE REMOVED PROPERLY. 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

    THIS REPORT IS FOR AN UNKNOWN MATRIXRIB SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AN OSTEOSYNTHESIS METAL REMOVAL WAS PERFORMED DUE TO AN INFECTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH MATRIXRIB STERNAL PLATES AND MATRIXRIB LOCKING SCREWS ON AN UNKNOWN DATE. THE DEVICES WERE SUCCESSFULLY REMOVED THROUGH A WINDOW IN THE STERNUM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS REPORT IS AN UNKNOWN MATRIXRIB SCREW. THIS IS REPORT 8 OF 10 FOR (B)(4). ADDITIONAL DEVICES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290297 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention