BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS

    MDR report key: 3915337 · Received July 7, 2014

    Report

    Report Number
    2530088-2014-10177
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH A LIGHT SCRATCH ON THE BOTTOM OF THE COLLAR. THIS IS NOT MANUFACTURE RELATED. ALL RELEVANT FEATURES WERE VERIFIED AND CONFORMED TO PRODUCT SPECIFICATIONS. COMPLAINT IS UNCONFIRMED. A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THIS TI COLLAR (PART 499.292, LOT 7654716) WAS RETURNED WITH THE COMPLAINT OF DOES NOT FIT WITH OTHER PARTS; HOWEVER, UPON EXAMINATION OF THE PART AND REVIEW OF THE MOST RECENT VERSION OF THE DRAWING TO WHICH THIS PART WAS MANUFACTURED TO IN APRIL 2014, IT WAS SEEN THAT THIS PART IS INTACT, MEETS THE DIMENSIONS OF THE DRAWING, AND OTHER THAN A MINOR SURFACE SCRATCH, SHOWS NO SIGNS OF DAMAGE, AND MATES PROPERLY WITH PART 499.294. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT. THIS COMPLAINT IS NOT CONFIRMED. THE SET CONTAINS INSTRUMENTS TO HELP PERSUADE/BEND THE RODS TO ACCOMMODATE A WIDE VARIETY OF SURGICAL INSTANCES AND PATIENT ANATOMY. SINCE THERE IS NOT ENOUGH INFORMATION CONCERNING THE PLACEMENT OF THE ROD DURING THE PROCEDURE, THIS COMPLAINT IS A DEEMED INVALID FROM A DESIGN PERSPECTIVE. THE COMPLAINT FOR THIS PART IS UNCONFIRMED GIVEN THE MEASUREMENTS AND THE VISUALLY ACCEPTABLE CONDITION THAT IT WAS RETURNED IN. 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 CROSS THREADED DURING INSERTION; DEVICE WAS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DURING A POSTERIOR L5 ¿ S1 FUSION A NUT CROSS THREADED ONTO A SCREW IN THE RIGHT L5 POSITION. THE SURGEON WAS PERFORMING THE POSTERIOR L5 ¿ S1 FUSION ON THE PATIENT USING TITANIUM UNIVERSAL SPINE SYSTEM DUAL OPENING DURING SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE SURGEON PLACED 8.0 X 50MM SCREWS IN S1 AND 7.0 X 50MM SCREWS IN L5. AFTER THE SCREWS WERE INSERTED, THE SURGEON PERFORMED THE DECOMPRESSION. THE SURGEON THEN CONNECTED THE RODS (498.290 ROD CUT INTO 2 RODS TO BE USED ON BOTH SIDES). WHILE CONNECTING THE RODS, THE SURGEON COULD NOT GET THE NUT TO THREAD ONTO THE SCREW LOCATED AT THE RIGHT L5. IT WAS REPORTED THAT THE NUT BECAME CROSS THREADED ONTO THE SCREW. THE SURGEON THEN TRIED ANOTHER NUT AND A COLLAR ON THE RIGHT L5 SCREW. THE NEW NUT BECAME CROSS THREADED. THE SURGEON THEN TRIED ANOTHER NUT AND IT THREADED ONTO THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED. THERE WAS A TEN MINUTE TIME DELAY. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394706 TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7654716

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR