BEUDAMED
    FDA Adverse Event Death Summary report: N

    TI 3.5X085 LOR ROD

    MDR report key: 11170752 · Received January 14, 2021

    Report

    Report Number
    1526439-2021-00149
    Event Type
    Death
    Date Received
    January 14, 2021
    Date of Event
    December 18, 2020
    Report Date
    December 18, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKG
    UDI-DI
    10705034511702
    PMA / PMN Number
    K181949
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. H10 ADDITIONAL NARRATIVE: D6A: UPDATED IMPLANTATION DATE. E1. UPDATED INITIAL REPORTER NAME. 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 · 1

    ADDITIONAL NARRATIVE: ADDITIONAL PROCODE: KWP. 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. 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 (B)(6) 2020, DURING POSTERIOR CERVICAL FUSION SURGERY THE PATIENT DIED. THE DEPUY SYNTHES SPINE SYSTEM UTILIZED IN THIS PROCEDURE WAS THE SYMPHONY OCT SYSTEM. THE INSTRUMENTATION OF THE SYMPHONY SCREWS WAS UNEVENTFUL. THE SURGEON FIRST INSTRUMENTED C4-6 LATERAL MASSES, THEN C2 PARS, AND FINALLY T1 PEDICLES. ALL SCREW PLACEMENTS WERE CONFIRMED BY THE SURGEON WITH FLUOROSCOPY. THE SURGEON PROCEEDED TO PERFORM THE DECOMPRESSION WITH A C3-7 LAMINECTOMY. AFTERWARDS THE SURGEON CHANGED THE VECTOR OF THE PATIENTS HEAD TO RE-ALIGN THE SPINE AFTER DECOMPRESSION. APPROXIMATELY TEN (10) MINUTES AFTERWARDS HE BEGAN PREPARING TWO (2) 4.0MM RODS. PRIOR TO INSTRUMENTATION OF THE RODS, THE PATIENT BEGAN TO LOSE SENSORY NEUROMONITORING SIGNALS. APPROXIMATELY FIVE (5) MINUTES LATER THE PATIENT LOSES MOTOR SIGNALS AND LOW BLOOD PRESSURE. AT THIS MOMENT THERE IS AN URGENCY TO COMPLETE THE CONSTRUCT AND CLOSE THE PATIENT. THE SURGEON DECIDED TO USE 3.5MM RODS INSTEAD. ALL RODS AND SET SCREWS WERE IMPLANTED AND FINAL TIGHTENED AS INTENDED. THE PATIENT WENT INTO CARDIAC ARREST APPROXIMATELY 5 MINUTES INTO CLOSING. APPROXIMATELY 1 HOUR AFTERWARDS, TIME OF DEATH WAS ANNOUNCED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SETSCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TI 3.5X085 LOR ROD. THIS IS REPORT 6 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70495 TI 3.5X085 LOR ROD ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG MEDOS INTERNATIONAL SàRL CH 1020-63-085 10705034511702

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death 4.0 PLY SCRW 3.5X12| 4.0 PLY SCRW 3.5X12| 4.0 PLY SCRW 4.0X18| 4.0 PLY SCRW 4.0X18| 4.0 PLY SCRW CFX 4.5X24| 4.0 PLY SCRW CFX 4.5X24| TI 3.5X080 LOR ROD| TI 4.0X075 LOR ROD| TI 4.0X075 LOR ROD| UNKNOWN LOCKING/SET SCREWS| 4.0 PLY SCRW 3.5X12| 4.0 PLY SCRW 3.5X12| 4.0 PLY SCRW 4.0X18| 4.0 PLY SCRW 4.0X18| 4.0 PLY SCRW CFX 4.5X24| 4.0 PLY SCRW CFX 4.5X24| TI 3.5X080 LOR ROD| TI 4.0X075 LOR ROD| TI 4.0X075 LOR ROD| UNKNOWN LOCKING/SET SCREWS