BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXRIB STRAIGHT PLATE 2.8MM THICK/8 HOLES

    MDR report key: 8495272 · Received April 9, 2019

    Report

    Report Number
    8030965-2019-62584
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    April 17, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07612334110633
    PMA / PMN Number
    K161590
    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. UPDATED EVENT DESCRIPTION. UPDATED PRO-CODE AND COMMON DEVICE NAME. : 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) CAPTURE THE OSTEOSYNTHESIS METAL REMOVAL DUE TO AN INFECTION WHILE PC-000419451 CAPTURES THE INTRA-OP EVENTS WHERE THE DEVICES INVOLVED COULD NOT BE REMOVED PROPERLY. OMIT (D1) BRAND NAME, (D2B.) PRO-CODE, (D2) COMMON DEVICE NAME, (D4) CATALOG, AND (D4) UDI FROM INITIAL REPORT MWR-01042019-0000387920. REPLACE WITH HWC, SCREW, FIXATION, BONE. 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. COMPLAINANT PART IS NOT RECEIVED AND NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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. 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

    DEVICE REPORT FROM SYNTHES SWITZERLAND 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 FOR AN UNK - SCREWS: MATRIXRIB. THIS IS REPORT 1 OF 10 FOR (B)(4). ADDITIONAL DEVICES ARE CAPTURED ON RELATED COMPLAINT (B)(4).UNK - SCREWS: MATRIXRIB.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 FOR AN 8-HOLE MATRIXRIB STERNAL PLATE. THIS IS REPORT 1 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
    290523 TI MATRIXRIB STRAIGHT PLATE 2.8MM THICK/8 HOLES SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 07612334110633

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention