BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 350MM

    MDR report key: 6295237 · Received February 1, 2017

    Report

    Report Number
    2520274-2017-10357
    Event Type
    Injury
    Date Received
    February 1, 2017
    Report Date
    January 11, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 HISTORY RECORD REVIEW WAS PERFORMED ON PART # 498.114, LOT # 8923955. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 16. APR 2014. NO (NON-CONFORMANCE REPORTS (NCRS) 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. CATALOG NUMBER UPDATED FROM STERILE TO NON-STERILE PART. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE PRODUCT CODES ARE MNI, MNH, KWP AND KWQ. (B)(4). THE REPORTED DEVICE IS STILL IMPLANTED IN THE PATIENT. REVISION SURGERY, ALTHOUGH ADVISED, HAS NOT YET BEEN SCHEDULED AS OF THE DATE OF THIS REPORT. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION AT THIS TIME. (B)(6). 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.

    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.

    Description of Event or Problem · 1

    EVENT WAS DETECTED POST-OPERATIVELY. THERE WAS NO PROLONGATION OF SURGERY. CONCOMITANT MEDICAL PRODUCTS: CLICK X PEDICLE SCREW (PART: 498.989, LOT: 9324352, QUANTITY: 4); CLICK X PEDICLE SCREW (PART: 498.990, LOT: 9316110, QUANTITY: 6); CLICK X PEDICLE SCREW (PART: 498.995, LOT: 8760151, QUANTITY: 2); CLICK X LOCKING CAP (PART: 498.570, LOT: 9297510 QUANTITY: 11).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT X-RAY TAKEN ON (B)(6) 2017 REVEALED DISPLACEMENT OF THE ROD OUT OF THE CLICK'X LOCKING CAP. THE IMPLANTS WERE INITIALLY IMPLANTED ON (B)(6) 2015. REVISION SURGERY WILL NEED TO BE PERFORMED BUT HAS NOT YET BEEN SCHEDULED. CONCOMITANT MEDICAL PRODUCTS: CLICK X PEDICLE SCREW (PART: 498.990, LOT: UNKNOWN, QUANTITY: 2); CLICK X PEDICLE SCREW (PART: 498.989, LOT: UNKNOWN, QUANTITY: 4); CLICK X PEDICLE SCREW (PART: 498.990, LOT: UNKNOWN, QUANTITY: 4); CLICK X PEDICLE SCREW (PART: 498.995, LOT: UNKNOWN, QUANTITY: 2); CLICK X LOCKING CAP (PART: 498.570, LOT: UNKNOWN, QUANTITY: 11). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77717 6.0MM TI HARD ROD 350MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB SYNTHES MEZZOVICO 8923955

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 498.570, TI CLICK'X® LOCKCAP TI 3-D HEAD, QTY 11| 498.989, 6.2MM TI CLICK'X® PEDICLE SCR 45MM, QTY 4| 498.995, 7.0MM TI CLICK'X® PEDICLE SCR 40MM, QTY 2