BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6817169 · Received August 24, 2017

    Report

    Report Number
    1000562954-2017-10210
    Event Type
    Injury
    Date Received
    August 24, 2017
    Report Date
    March 7, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL PRODUCT CODES: MNH, MNI, KWP, KWQ. PART NUMBER 498.570 AND TWO POSSIBLE LOT NUMBERS, 931519 AND 9315194 WERE PROVIDED FOR TWO LOCKING CAPS. IT IS UNKNOWN IF THESE DEVICES WERE EXPLANTED IN THIS CASE. ADDITIONAL QUANTITY OF LOCKING CAPS IS UNKNOWN. LOT 931519 IS INVALID, NO DHR REVIEW IS POSSIBLE FOR THIS LOT. DHR REVIEW IS FOR VALID LOT 9315194. (B)(4) LOT NUMBER UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS COMPLETED FOR THE TWO POSSIBLE LOT NUMBERS. PART NUMBER: 498.570 LOT NUMBER: 9315194. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 23 DECEMBER 2014. NO 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. 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 THE PATIENT EXPERIENCED AN INFECTION TWO DAYS AFTER THE REMOVAL OF SYNTHES IMPLANTS ON (B)(6) 2016. THE PATIENT WENT HOME AND DEVELOPED A FEVER (102 DEGREES) AND LATER REPORTED FEELING SICK WITH CHILLS, BEING IN A SIGNIFICANT AMOUNT OF PAIN, WEAKNESS DIARRHEA. THE PATIENT WAS HOSPITALIZED FOR SEVERAL DAYS. DURING THAT TIME PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS RE-ADMITTED AND ANOTHER SURGERY WAS DONE ON (B)(6) 2016 FOR AN ABSCESS FORMATION AT THE PREVIOUS SURGERY SITE. MILD LEUKOCYTOSIS WAS NOTED. CREATININE WAS NOTED TO BE ELEVATED FROM NORMAL TO 2.5. THE SURGEON REMOVED ALL COMPETITOR¿S HARDWARE FROM L4 ¿ S1, CLEANED THE WOUND, AND REPLACED WITH NEW NON SYNTHES PEDICLE SCREWS AND FUSION WITH PLACEMENT OF BONE ALLOGRAFT AND A COMPETITOR'S ELEVATE IMPLANT. A VACUUM PUMP DEVICE WAS PLACED AND THE PATIENT WAS STARTED ON ANTIBIOTICS. IT WAS RECOMMENDED THAT THE PATIENT CONTINUE IV ANTIBIOTICS FOR A 6-WEEK COURSE. THE PATIENT REPORTED TO HER SURGEON ON (B)(6) 2016, WITH CONCERNS OF TENDERNESS TO THE AREA OF HER LOWER BACK WHERE SHE HAS A DRAIN TUBE IN PLACE FOR SEVERAL WEEKS FOLLOWING HER LUMBAR SPINE SURGERY THAT WAS COMPLICATED BY A POSTOPERATIVE INFECTION. THE DRAIN TUBE WAS REMOVED SEVERAL DAYS PRIOR AND TWO DAY BEFORE HER VISIT, SHE NOTED SORENESS AND THERE WAS SOME REDNESS IMMEDIATELY TO THE SKIN AROUND THE DRAIN TUBE SITE. SLIGHT ERYTHEMA NOTED ON THE LOWER BACK WITH A LESS THAN 1 CM ESCHAR WITH A DRAIN TUBE. REPORTEDLY SHE HAD A SKIN REACTION FROM THE TAPE PLACED ON HER SKIN. OVERALL THE PATIENT REPORTED FEELING BETTER, WITH IMPROVED MOBILITY AND SHE REPORTS NO LONGER HAVING TO USE A WALKER OR CANE. ON (B)(6) 2016 THE PATIENT REPORTED DURING A POSTOPERATIVE VISIT THAT SHE HAS MADE CONTINUED IMPROVEMENT IN HER LEVEL OF PAIN AND OVERALL MOBILITY AND REPORTEDLY CONTINUED WITH PHYSICAL THERAPY. PATIENT STILL HAS TO BE CAREFUL WITH POSITION CHANGES INVOLVING HER LOWER BACK AND SHE CAN STILL GET PAIN ISSUES. AT TIMES SHE HAS A RIGHT ANTERIOR LOWER LEG PARESTHESIA AS THOUGH ¿A FLY IS CRAWLING AROUND ON THE FRONT OF THE LEG" THAT SHE WILL NOTICE PRIMARILY WHEN SHE HAS TO SIT FOR A LONG PERIOD OF TIME. SHE REPORTED HER MOOD HAS BEEN STABLE. SHE REPORTED TO HAVE BEEN OFF THE ANTIBIOTICS FOR THE POSTOPERATIVE WOUND INFECTION FOR A FEW WEEKS. THE PATIENT STILL REPORTED BACK PAIN ISSUES IN THE LUMBAR REGION AND VERY LIMITED RANGE OF MOTION IN (B)(6) 2016. THIS REPORT IS FOR ONE (1) CLICKX LOCKING CAP IMPLANTED AT S1 RIGHT. THIS IS REPORT 9 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596893 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