BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX

    MDR report key: 12177662 · Received July 15, 2021

    Report

    Report Number
    8030965-2021-05813
    Event Type
    Injury
    Date Received
    July 15, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. 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

    THIS REPORT IS FOR ONE (1) TELEFIX DOUBLE ROD IMPLANT TITAN 35 - 45MM.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ARCOFIX/TELEFIX/VENTROFIX: TELEFIX IMPLANT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT OSTEOSYNTHESIS EIGHT YEARS AGO DUE TO AN ACCIDENT WITH AN LWK 1 FRACTURE. SINCE IMPLANTATION, PATIENT HAS BEEN FEELING DISCOMFORT. PATIENT ALSO HAS CONSTANT PAIN IN THE AFFECTED AREA. PART OF THE IMPLANTED CONSTRUCT WAS REMOVED IN 2014. THIS REPORT IS FOR AN UNKNOWN ARCOFIX/TELEFIX/VENTROFIX: TELEFIX IMPLANT. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069113 UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX| UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX| UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX| UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX| UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX