BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH

    MDR report key: 5631651 · Received May 4, 2016

    Report

    Report Number
    2520274-2016-12533
    Event Type
    Injury
    Date Received
    May 4, 2016
    Report Date
    April 19, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. LOT NUMBER 8220481 PROVIDED; IT IS UNKNOWN IF IT BELONGS TO ONE OF THE COMPLAINED SCREWS. (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A VALID 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.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: A VISUAL INSPECTION CONDUCTED DURING THIS INVESTIGATION IDENTIFIED THAT TWO (2) SCREWS WERE RECEIVED IN BROKEN CONDITIONS. THE REMAINING EIGHT DEVICES, WHICH INCLUDES THE DEVICE (PART 498.989/LOT 8220481) CAPTURED IN THIS REPORT, SHOW NO DAMAGE. NO FURTHER INVESTIGATION WAS REQUIRED FOR THE UNDAMAGED PARTS. DEVICE 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

    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

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. UPDATED DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: DECEMBER 20, 2012. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REPORT REPRESENTS AN ¿ADVERSE EVENT¿ ONLY. THERE IS NO REPORTED PRODUCT PROBLEM WITH THIS DEVICE. DEVICE 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A TRANSPEDICULAR FIXATION SYSTEM AT L4-L5 ON (B)(6) 2013. DURING ANOTHER PROCEDURE IT WAS OBSERVED THAT THE LEFT SCREW AT L4 WAS BROKEN FROM THE BASE, THE LEFT SCREW AT L5 WAS BROKEN FROM THE MEDIAL PORTION, AND THE RIGHT SCREW WAS BROKEN IN THE PREASSEMBLED CAP AREA. DURING THE EXPLANT SURGERY OF THE SYSTEM A SCREW HALF FROM ONE OF THE BROKEN SCREWS WAS LEFT INSIDE THE PATIENT; THE REST OF THE HARDWARE WAS REMOVED FROM THE PATIENT. IN ADDITION IT WAS NOTED THERE WAS A BROWNISH BLACK SUBSTANCE IN THE REGION WHERE THE SCREWS AND RODS WERE PLACED ON THE RIGHT SIDE. NO PROLONGATION OF THE EXPLANT SURGERY WAS REPORTED. THIS IS REPORT 3 OF 10 FOR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT VISITED THE DOCTOR BECAUSE SHE FELT PAIN; THE SURGEON SCHEDULED THE REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287139 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO 8220481

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention