BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS

    MDR report key: 3101363 · Received May 9, 2013

    Report

    Report Number
    2530088-2013-00784
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NO NON CONFORMITIES WERE GENERATED DURING PRODUCTION. 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. ONE DEEP SCRATCH AND TWO MINOR SCRATCHES ON THE FACE OF THE COLLAR WHERE THE ANODIZE FINISH HAS BEEN REMOVED. THIS IS NOT MANUFACTURE RELATED. THE MATERIAL WAS TESTED AND MET SPECIFICATIONS. ALL RELEVANT FEATURES MEASURED MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE SURGEON HAD DIFFICULTY ENGAGING THE NUTS ON THE S1 SCREW. THIS MAY HAVE BEEN DUE TO THE ROD NOT BEING FULLY SEATED IN THE SCREW. THE DAMAGE TO THE COLLAR AND THREADS INDICATE THAT THE ROD WAS PUSHING OUTWARD AND UPWARD DURING THE ATTEMPTED ENGAGEMENT OF THE NUTS. ALL RETURNED NUTS AND SCREW SHOW DAMAGE TO THE MATING THREADS. THE MATERIALS WERE REVIEWED AND ARE ADEQUATE FOR THE INTENDED USE. (B)(4). THE DESIGN RISK ASSESSMENT WENT FOR REVIEW BY PRODUCT DEVELOPMENT FOR THIS COMPLAINT EVENT. THE SET CONTAINS INSTRUMENTS TO HELP PERSUADE/ BEND THE RODS TO ACCOMMODATE A WIDE VARIETY OF SURGICAL INSTANCES AND PATIENT ANATOMY. THERE IS NOT ENOUGH INFORMATION AS TO THE PLACEMENT OF THE ROD DURING THE PROCEDURE.

    Description of Event or Problem · 1

    DURING A L4-S1 POSTERIOR FUSION WITH USS DUAL OPENING SYSTEM SURGERY ON (B)(6) 2013, AT THE END OF THE PROCEDURE, THE TI 12-POINT NUT WOULD NOT ENGAGE THE LEFT S1 SCREW. THE SURGEON TRIED SEVERAL NEW NUTS, BUT COULD NOT GET THEM TO ENGAGE. HE TRIED IMPACTING THE NUT SEVERAL TIMES TO GET THE NUT TO ENGAGE, BUT ENDED UP CROSS THREADING THE NUT ONTO THE TOP OF THE SCREW HEAD. WHEN FINAL TIGHTENING THE NUT ON THE S1 SCREW, IT WOULD NOT TORQUE OUT AND THE THREADS ON THE SCREW HEAD WERE STRIPPED. HE REPLACED THE STRIPPED LEFT S1 SCREW WITH ONE DIAMETER BIGGER AND WAS ABLE TO ENGAGE THE NUT SUCCESSFULLY WITH A NEW NUT AND COLLAR. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY OR ANY HARM TO THE PATIENT REPORTED. THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202950 TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS NKB SYNTHES BRANDYWINE 7317688

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR