BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT, CUTTING, ORTHOPEDIC

    MDR report key: 8116702 · Received November 29, 2018

    Report

    Report Number
    2939274-2018-55158
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 13, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THERE ARE NO ADDITIONAL PROCODES FOR THIS UNKNOWN CHISEL. 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 AN UNKNOWN CHISEL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: EMM, FZO. THIS REPORT IS FOR AN UNKNOWN CUTTING INSTRUMENTS: CHISEL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, A PRIMARY CHISEL WAS USED TO CUT THE KEEL PRIOR TO INSERTING THE IMPLANT AND THE VERTEBRAL BODY CRACKED SLIGHTLY. THE SURGEON NOTED THE FRACTURE WOULD NOT WORSEN OR CAUSE INSTABILITY SO HE IMPLANTED THE PRODISC-C. IT WAS FURTHER REPORTED THAT IN NO WAY IS THIS ASSOCIATED WITH THE PRODISC-C AS IT OCCURRED AFTER THE APPROPRIATE TRIAL WAS SELECTED AND THE KEEL WAS BEING CUT WITH THE CHISEL. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956885 INSTRUMENT, CUTTING, ORTHOPEDIC HTZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention