BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNREAM REAMING ROD Ø2.5 SHORT L950

    MDR report key: 2882329 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04249
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A PATIENT TREATED IN A STAGED OPERATION WITH A FEMORAL LISS PLATE IMPLANT AND A REAMER IRRIGATOR ASPIRATOR RIA. IN MID (B)(6) 2012, THE SURGEON CONDUCTED AN ACUTE LEG LENGTHENING PROCEDURE, APPROX 3CM. IT WAS NOTED THAT THE PATIENT ALREADY HAD A LONG STEM HIP PROSTHESIS IMPLANTED IN A PRIOR SURGERY, UNKNOWN DATE. A 5-HOLE SS DF LISS PLATE WAS USED WITH LOCKING SCREWS DISTALLY AND LOCKING SCREWS PROXIMALLY. THE SURGEON PLATED TO THE LEVEL OF THE LONG HIP STEM. ON (B)(6) 2012, A SECOND OPERATION WAS CONDUCTED TO OBTAIN GRAFT FROM THE CONTRA LATERAL FEMUR USING RIA PROCEDURE. THIS GRAFT WAS THEN USED TO FILL THE VOID FROM THE ACUTE LENGTHENING PROCEDURE. (B)(6) 2012, THE SURGEON REVISED THE LISS PLATE FIXATION BECAUSE THE PROXIMAL LOCKING SCREWS HAD STARTED TO PULL OUT. THE LISS PLATE WAS REMOVED WITHOUT INCIDENT; THE PATIENT WAS RE-SHORTENED AND THEN FIXED INTERNALLY WITH AN 8 HOLE VA CONDYLAR PLATE WITH CABLES AND PERIPROSTHETIC SCREWS PROXIMALLY. AT THIS CASE, IT WAS ALSO REVEALED THAT THE PATIENT HAD A LONG GAMMA NAIL IMPLANTED, UNKNOWN DATE, IN THE OPPOSITE FEMUR DUE TO A LONG SPIRAL FRACTURE THAT OCCURRED IN THE POSTOPERATIVE PERIOD FOLLOWING THE RIA PROCEDURE. REPORTEDLY, THE REVISION PROCEDURE WAS COMPLETED WITHOUT COMPLICATION AND WITH NO ADVERSE EVENT REPORTED TO DATE. THIS IS REPORT #1 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNREAM REAMING ROD Ø2.5 SHORT L950 REAMING ROD HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention