BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DISTRACTION LOCK

    MDR report key: 2870699 · Received December 12, 2012

    Report

    Report Number
    2530088-2012-01077
    Event Type
    Injury
    Date Received
    December 12, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICE AND NOTED SLIGHT SCRATCHES ARE VISIBLE ON THE TOP SURFACE CONSISTENT WITH NORMAL USE. THE TIP OF THE CENTER PIN WAS WORN HEAVILY WHICH IS ALSO CONSISTENT WITH NORMAL USE. THE MEDIAL EDGES OF THE TABS WERE EXAMINED FOR MATERIAL DISPLACEMENT THAT WOULD INDICATE THE LOCK HAD BEEN PROPERLY SEATED ON THE MATING PART. ONLY ONE OF TWO EDGES SHOWED MATERIAL DISPLACEMENT. DISTRACTION LOCKS ENGAGE THE RIB SLEEVE AS WELL AS THE SUPERIOR OR INFERIOR MATING COMPONENTS. IT MAINTAINS THE DESIRED POSITION OF THE CONSTRUCT COMPONENTS IN RELATION TO ONE ANOTHER. THE RETURNED DEVICE SHOWS MATERIAL DISPLACEMENT ON ONLY ONE SIDE WHICH INDICATES THE LOCK WAS NOT PROPERLY ASSEMBLED TO THE CONSTRUCT. LOCK CRIMPER (388.474) IS PROVIDED WITH THE SYSTEM TO COMPLETED SEAT THE DISTRACTION LOCK. IT IS POSSIBLE THIS INSTRUMENT WAS NOT USED. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE DEVICE WAS IMPLANTED APPROXIMATELY 6-7 YEARS PRIOR TO THE EXPLANT DATE. THE DEVICE WAS RECEIVED WITH SEVERAL HEAVY GOUGES ON THE INTERIOR SURFACE AND EDGES WITH ANODIZE REMOVAL. THIS POST MANUFACTURING DAMAGE IS CONSISTENT WITH FIELD USE. THE DEVICE CONFORMS TO PRODUCT TOP LEVEL SPECIFICATIONS. NO ABNORMALITIES WERE NOTED DURING THE DEVICE HISTORY RECORD REVIEW. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    PATIENT HAD A VEPTR IMPLANT CONSTRUCT PROCEDURE DONE 6-7 YEARS AGO AT T2-T3 TO THE ILLUM. POSTOPERATIVELY, IT WAS NOTED THAT THE DISTRACTION LOCK HAD POPPED OFF AND WAS DISLODGED OVER THE RIB SLEEVE. THE PATIENT WAS HAVING A FEW SURGERIES DONE BY ANOTHER ORTHOPEDIC SURGEON. THE SURGEON NOTICED THE DISTRACTION LOCK HAD POPPED OFF AND WAS DISLODGED OVER THE RIB SLEEVE. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012. IT WAS NOTED THAT NONE OF THE DEVICES WERE BROKEN. THE PATIENT HAD NOT COMPLAINED OF ANY PAIN, INFECTION, OR REACTION TO THE DEVICES. THE SURGEON RE-DRAPED THE PATIENT AND MADE AN INCISION TO REPLACE THE LOCK AND PUT IN ANOTHER COMPONENT IN WHICH IS CONSIDERED NORMAL AT A CERTAIN PART AFTER EXPANSION. THE PATIENT WAS BEYOND APEX OF THE DEVICE, THE SURGEON USED A LARGER VEPTR 2 ADAPTER PROXIMAL EXTENSION WITH NEW A LOCK. THE REVISION WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI DISTRACTION LOCK DISTRACTION LOCK MDI SYNTHES BRANDYWINE 6550478

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention RIB SLEEVE, DISTRACTION LOCK