BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN CALAXO SCREW

    MDR report key: 2760233 · Received June 22, 2007

    Report

    Report Number
    1219602-2007-00121
    Event Type
    Other
    Date Received
    June 22, 2007
    Report Date
    June 20, 2007
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REINFORCED SURGICAL TECHNIQUE TO CUSTOMER. SURGEON MUST COUNTERSINK CALAXO SCREWS AT LEAST 3MM ON THE TIBIAL SIDE. NO PRODUCT WAS BEING RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    EMAIL RECEIVED WITH ADDITIONAL INFO ON (B)(6) 2007, INDICATED A REVISION SURGERY FOR 1990'S ACL. NO ISSUES AT TIBIAL TUNNEL SITE AT 5 MONTHS POST-OP ((B)(6) 2006), BUT WITHIN A MONTH HAD SUDDEN OVERNIGHT SWELLING AT TIBIAL SITE. REMOVED ABOUT 7 ML OF CLEAR FLUID AND 2 ML OF SCREW MATERIAL FROM TUNNEL (BOTH NEGATIVE CULTURES) AND TUNNEL HAD WIDENED. PT HAD EPISODES OF INSTABILITY, AND ON (B)(6) 2006, HAD PARTIAL TEARING OF ACL. HAD PROMINENT MASS OVER TIBIAL TUNNEL. PERFORMED THERMAL SHRINKAGE TO TIGHTEN GRAFT. TIBIAL SIDE HAD LARGE AMOUNT OF PURULENT MATERIAL. THE SCREW WAS DISLODGED. DEBRIDED THE PART OUTSIDE THE BONE - CHALKY SUBSTANCE. LAST WEEK HAD MORE PAIN AND SWELLING ON THE TIBIAL SIDE. THE DR. BELIEVES THE TIBIAL TUNNEL IS IN JEOPARDY, HAS WIDENED. THE SCREW RESIDUAL MAY BE CAUSING CONTINUED PROBLEMS. FIXATION MAY BE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CALAXO SCREW NONE HWC SMITH & NEPHEW INC., ENDOSCOPY DIV. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1