BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS TI CFX FEN POLY 6X50

    MDR report key: 9396644 · Received December 2, 2019

    Report

    Report Number
    1526439-2019-52525
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 6, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    PML
    UDI-DI
    10705034282572
    PMA / PMN Number
    K160879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    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. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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. ADDITIONAL NARRATIVE: DEVICE HISTORY (LOT), PRODUCT CODE: 186727650, LOT #: 230626. DEVICE HISTORY REVIEW, THE DHR OF PRODUCT CODE 186727650, LOT 230626, WAS REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON (B)(6) 2019. VISUAL INSPECTION OF THE IMPLANT SHOWED NO ISSUES WITH THE SCREW, NO DAMAGE WAS NOTED. REVIEW OF THE X-RAYS PROVIDED (3 IMAGES FROM THE ATTACHMENT(S) LOCATED IN NOTES & ATTACHMENTS SECTION OF THE PRODUCT COMPLAINT); SHOWED THAT THE SET SCREW SEPARATED FROM THE SCREW RESULTING IN THE SCREW LOOSENING FROM THE ROD. FUNCTIONAL TEST: THE COMPLAINT CONDITION COULD NOT BE REPLICATED AS THE SET SCREW WAS ABLE TO BE TIGHTENED WITH THE SCREW AND DID NOT BECOME LOOSE. CONCLUSION: THE COMPLAINT CONDITION OF IS CONFIRMED. NO NEW ISSUES WERE IDENTIFIED ON THE REMAINING PORTIONS OF THE DEVICE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Description of Event or Problem · 0

    3 WEEKS POST OP IT WAS OBSERVED AN BIPER INNER SET SCREW LOOSENING ON THE X-RAY, THE SET SCREW WAS LOST FROM THE SCREW AND THE CONSTRUCT NEEDED TO BE REVISED. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES THREE (3) DEVICES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: MNI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THREE (3) WEEKS POST OP IT WAS OBSERVED AN BIPER INNER SET SCREW LOOSENING ON THE X-RAY. THE SET SCREW WAS LOST FROM THE SCREW AND THE CONSTRUCT NEEDED TO BE REVISED. PATIENT WAS INITIALLY IMPLANTED ON (B)(6) 2019. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191536 MIS TI CFX FEN POLY 6X50 BONE CEMENT, POSTERIOR SCREW AUGMENTATION PML MEDOS INTERNATIONAL SàRL CH 186727650 230626 10705034282572

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention