BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNABUNION PLATE, 18MM, LEFT, STERILE

    MDR report key: 16053024 · Received December 27, 2022

    Report

    Report Number
    3020584246-2022-00064
    Event Type
    Injury
    Date Received
    December 27, 2022
    Report Date
    December 27, 2022
    Manufacturer
    SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    HRS
    UDI-DI
    00815432028788
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. ADDITIONAL NARRATIVE: BRAND NAME: THE MOTOBAND¿ CP DYNAFORCE® IMPLANT SYSTEM IS A BONE PLATING SYSTEM INDICATED FOR STABILIZATION AND FIXATION OF FRESH FRACTURES, REVISION PROCEDURES, JOINT FUSION AND RECONSTRUCTION OF SMALL BONES OF THE HAND, FEET, WRIST, ANKLES, FINGERS AND TOES. IT CONSIST OF PLATES AND SCREWS. CERTAIN PLATES IN THE SYSTEM ARE COMPATIBLE WITH THE MOTOCLIP/DYNAFORCE SUPERELASTIC FIXATION SYSTEM. PROCODE: ADDITIONAL DEVICE PRODUCT CODES: HWC, JDR. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER OCCUPATION: REPORTER IS A J&J EMPLOYEE. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT THOUGHT THAT SHE MIGHT BE HAVING AN ALLERGIC REACTION TO A PLATE AFTER HER SURGERY. SHE HAD A CROSSROADS EXTREMITY SYSTEMS PLATE IMPLANTED APPROXIMATELY 14 WEEKS PRIOR TO ON (B)(6) 2022. THE IMPLANTS WILL NOT BE RECOVERED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE THE MOTOBAND¿ CP DYNAFORCE® IMPLANT SYSTEM IS A BONE PLATING SYSTEM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136292 DYNABUNION PLATE, 18MM, LEFT, STERILE PLATE, FIXATION, BONE HRS SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC DynaBunion Plate 18mm Left Single Pack 00815432028788

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention DYNAFORCE HIMAX IMPLANT KIT