BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR SYNAPSE TAN

    MDR report key: 7272954 · Received February 15, 2018

    Report

    Report Number
    8030965-2018-51118
    Event Type
    Injury
    Date Received
    February 15, 2018
    Report Date
    February 21, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    UDI-DI
    07611819328747
    PMA / PMN Number
    K142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 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 DEVICE PRODUCT CODES: KWP, MNH, MNI. THERAPY DATE: (B)(6) 2017. 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

    THE REVISION SURGERY PERFORMED ON (B)(6) 2018, WAS COMPLETED WITHOUT ANY PROBLEM. SINCE THERE WAS NO REMARKABLE SCRATCH ON THE PLATE SIDE, THE DISLODGED SET SCREW WAS REMOVED, AND A NEW SET SCREW WAS USED FOR TIGHTENING. THE SURGEON COMMENTED THAT THERE WAS NOTHING TO DO WITH THE DEVICE ITSELF.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID, AGE, DOB & WEIGHT NOT PROVIDED FOR REPORTING. UNKNOWN WHEN THE DEVIATION OF THE SCREWS STARTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6) . ADDITIONAL 510K: K090549 & K070573 . THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS 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. (B)(4). 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE SPINE SURGERY WAS PERFORMED BY USING SYNAPSE 4.0 SYSTEM. THE FIXED AREA WAS O¿C5. DURING THE SURGERY, THE ROD WAS PLACED BY BENDING AT MORE THAN A 90 DEGREE ANGLE SINCE THE POSITION OF THE OCCIPITAL BONE AND CERVICAL SPINE WAS CLOSE TO EACH OTHER. THE FINAL TIGHTENING WAS PERFORMED, AND IT WAS CONFIRMED THAT THERE WAS NO PROBLEM BY THE POST-OPERATIVE X-RAY IMAGES. ON (B)(6) 2018, IT WAS FOUND THAT THE SET SCREW FOR WHICH THE OCCIPITAL PLATE AND THE ROD WERE SET UP, HAD BEEN DEVIATED ON THE BOTH SIDES. THE REVISION SURGERY WAS COMPLETED ON (B)(6) 2018 WITH A DELAY, UNKNOWN HOW LONG, HOWEVER, THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: 1X 04.615.601S / LOT UNK (OCCIPITAL-PL 4.5/5 MED W/50 F/R Ø4 TI). THIS COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 1 OF 2 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117552 LOCKSCR SYNAPSE TAN ORTHOSIS, CERVICAL PEDICLE, SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH 07611819328747

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention