BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICK'X® LOCKING CAP FOR TI3-D HEAD

    MDR report key: 6816557 · Received August 24, 2017

    Report

    Report Number
    1000562954-2017-10200
    Event Type
    Injury
    Date Received
    August 24, 2017
    Report Date
    July 25, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S HEIGHT REPORTED AS (B)(6). DATE OF POST-OPERATIVE INFECTION DEVELOPMENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: MNH, MNI, KWP, KWQ. TWO POSSIBLE LOT NUMBERS, 931519 & 9315194 WERE PROVIDED FOR TWO LOCKING CAPS. IT IS UNKNOWN IF THESE LOT NUMBERS CORRESPOND TO THIS PART 498.570, WHICH WAS IMPLANTED ON (B)(6) 2015. LOT 931519 IS INVALID; NO DHR REVIEW IS POSSIBLE FOR THIS LOT. DHR REVIEW IS FOR VALID LOT 9315194. (B)(4). INFECTION WAS IDENTIFIED ON (B)(6) 2015; HOWEVER THE DEVICE WAS EXPLANTED ON (B)(6) 2016. THIS IMPLANT REMOVAL SURGERY HAS BEEN REPORTED UNDER LINKED COMPLAINT (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 498.570, AND POSSIBLE LOT NUMBERS 931519 & 9315194: PART NUMBER: 498.570, LOT NUMBER: 9315194: MANUFACTURING LOCATION: (B)(6), MANUFACTURING DATE: 23 DECEMBER 2014: NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. PART NUMBER: 498.570 INVALID LOT NUMBER: 931519 :UNKNOWN ARTICLE AND LOT NUMBER COMBINATION FOR SYNTHES (B)(4) SYSTEMS; DHR REVIEW NOT POSSIBLE. 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 A PATIENT WHO WAS IMPLANTED WITH A SYNTHES CLICK X SYSTEM ON (B)(6) 2015 DEVELOPED AN INFECTION THAT WAS TREATED ON OR ABOUT (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS REPORTED TO HAVE A VACUUM PUMP DEVICE PLACED IN THE LUMBOSACRAL REGION WITH A PIC LINE IN PLACE IN HER UPPER LEFT ARM. THE PHYSICIAN¿S ASSESSMENT DOCUMENTED THAT THE PATIENT HAD DEGENERATIVE LUMBAR SPINAL STENOSIS AND, IN SPITE OF HER RECENT SURGERY, HER MOBILITY, IRREGULAR GAIT, AND PAIN ISSUES HAD NOT SIGNIFICANTLY IMPROVED; PATIENT CANNOT WORK AN 8 HOUR JOB. THIS IS FOR THE TI CLICK'X® LOCKING CAP FOR TI3-D HEAD IMPLANTED AT S1 ON THE RIGHT. THIS IS REPORT 9 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597777 TI CLICK'X® LOCKING CAP FOR TI3-D HEAD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention