BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI 12-POINT NUT-11MM

    MDR report key: 2930168 · Received January 25, 2013

    Report

    Report Number
    2530088-2013-00090
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. ADDITIONAL CODES: MNH, MNI, KWQ, KWP. THE IMPLANTS IN THE COMPLAINT ARE PART OF THE USS DUAL-OPENING NON-CERVICAL SPINAL FIXATION SYSTEM. THIS SYSTEM IS INDICATED AS AN ADJUNCT TO FUSION. THE DESIGN RISK ANALYSIS DOES NOT ADDRESS THE PATIENT RISK IF THE SPINE FUSES AS INTENDED. AS DESCRIBED IN THE COMPLAINT DESCRIPTION, ADJACENT LEVEL DISC DISEASE IS THE REASON FOR THE REVISION SURGERY. BASED ON THE CURRENT EVIDENCE, THE CAUSES OF ADJACENT LEVEL DISC DISEASE REMAIN UNKNOWN. THE DESIGN OF THE INDIVIDUAL IMPLANTS ASSOCIATED WITH THIS COMPLAINT DID NOT CONTRIBUTE TO THE COMPLAINT. THE COMPLAINT DESCRIBES TWO EVENTS THAT CAN OCCUR WHEN REVISING AN EXISTING PEDICLE SCREW CONSTRUCT. THE SURGEON HAD DIFFICULTY USING NEW NUTS ON EXISTING SCREWS. ALL RETURNED SCREWS AND NUTS SHOW DAMAGE TO THE MATING THREADS. WHEN REMOVING EXISTING HARDWARE, THE EXPOSED EXTERNAL THREADS ARE SUSCEPTIBLE TO DAMAGE. THIS POTENTIAL THREAD DAMAGE WOULD PREVENT PROPER NUT ENGAGEMENT. THE COMPLAINT DESCRIPTION ALSO DESCRIBES A LOOSE SCREW DISCOVERED DURING THE REVISION. THE COMPLAINT DOES NOT SPECIFICALLY IDENTIFY THIS SCREW. A HOST OF PATIENT FACTORS CAN CONTRIBUTE TO A SCREW WITH POOR BONE PURCHASE. ALL OF THE RETURNED BONE SCREWS HAVE PRISTINE BONE THREADS. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH USS DUAL OPENING LUMBAR FUSION AT L4-L5 ON AN UNKNOWN DAY IN (B)(6) 2012. ON AN UNKNOWN POST-OPERATIVE DATE, PATIENT DEVELOPED ADJACENT LEVEL DISC DISEASE. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. SURGEON REMOVED THE USS DUAL OPENING NUTS COLLARS, AND RODS. NEW DUAL OPENING SCREWS WERE PLACED AT L2, L3, S1, AND ILIAC. ONE SCREW FROM THE PREVIOUS L4-L5 WAS REPLACED WITH A NEW SCREW BECAUSE IT WAS LOOSE. IT IS UNKNOWN AT WHICH LEVEL OR WHICH SIDE. SURGEON PLACED NEW RODS BUT DURING THE PROCEDURE, EXPERIENCED DIFFICULTIES GETTING A NUMBER OF THE NUTS TO THREAD ONTO THE SCREW HEADS WHILE PLACING THE RODS. FOUR OF THE SCREWS HAD THE TOP HEADS STRIP WHEN TRYING TO THREAD AND THE NUTS ALSO HAD TO BE REPLACED. NEW NUTS AND COLLARS WERE USED DURING THE PROCEDURE. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AND SECURE THE RODS TO ALL THE SCREWS WITH NUTS AND COLLARS. THIS IS 25 OF 32 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35769 TI 12-POINT NUT-11MM 12 POINT NUT NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR