BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM BROAD LCP® PLATE 14 HOLES/260MM

    MDR report key: 15668411 · Received October 25, 2022

    Report

    Report Number
    1719045-2022-00026
    Event Type
    Injury
    Date Received
    October 25, 2022
    Manufacturer
    MONUMENT DEPUY SYNTHES PRODUCTS INC
    Product Code
    HRS
    UDI-DI
    10886982159212
    PMA / PMN Number
    K082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. EVENT DATE: UNKNOWN WHEN THE DEVICE BROKE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 HISTORY: PART: 226.641; LOT: L882231; RELEASE TO WAREHOUSE DATE: 02 MAY 2018; MANUFACTURING SITE: (B)(4); EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED A PLATE WAS IMPLANTED ON AN (B)(6) 2022, BUT BROKE POST-OPERATIVELY ON AN UNKNOWN DATE. A REVISION SURGERY OCCURRED ON (B)(6) 2022 AND A NEW PLATE IMPLANTED. THE SECOND PLATE ALSO BROKE POST-OPERATIVELY. THERE WAS NO SURGICAL DELAY AND NO FRAGMENTS WERE LEFT BEHIND IN THE PATIENT. THIS COMPLAINT CAPTURES THE RUPTURE OF THE FIRST PLATE IMPLANTED. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN LCP PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573670 4.5MM BROAD LCP® PLATE 14 HOLES/260MM PLATE, FIXATION, BONE HRS MONUMENT DEPUY SYNTHES PRODUCTS INC 226.641 L882231 10886982159212

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention