BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTREMILOCK FOOT PLATING SYSTEM

    MDR report key: 4532535 · Received February 18, 2015

    Report

    Report Number
    2027754-2015-00002
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    February 2, 2015
    Report Date
    February 18, 2015
    Manufacturer
    OSTEOMED L.P.
    Product Code
    HRS
    PMA / PMN Number
    K133691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THIS IS THE FIRST COMPLAINT FOR THIS PRODUCT. THE PART WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, AN EVALUATION OF THE PART AND DHR COULD NOT BE PERFORMED. AN ASSESSMENT OF THE OSTEOMED PRODUCTS UTILIZED, IN COMPARISON TO THE LABELING, SHOW THAT THE COMBINATION OF PRODUCTS USED WERE APPROPRIATE. PER THE IFU, THE EXTREMILOCK SYSTEM IMPLANTS ARE FOR TEMPORARY FIXATION ONLY UNTIL OSTEOGENESIS OCCURS. THE TIME BETWEEN THE 2ND AND 3RD SURGERY EXCEED TEN (10) MONTHS. THE IFU ALSO PROVIDES WARNINGS CONCERNING SITUATIONS THAT COULD CAUSE IMPLANT FAILURES/FRACTURES. THE REVIEW OF THE EXTREMILOCK FOOT PLATING SYSTEM FMEA, REV. B SHOWS THAT FAILURE MODES CONCERNING THE STRENGTH OF THE PLATES HAVE A SEVERITY OF 3. THE PROBABILITY RANGE IS LISTED AS 2 FOR INADEQUATE DESIGN, AND "1" FOR PHYSICIAN OR PATIENT ERRORS. IN THE CASE OF AN INADEQUATE DESIGN, THE RISK LEVEL WOULD BE "MEDIUM". IN THE CASE OF PHYSICIAN OR PATIENT ERRORS, THE RISK LEVEL IS "LOW". THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING. QA NOTE: DURING AN AUDIT OF MDR SUBMISSIONS, WE IDENTIFIED THAT THE FOLLOW UP FOR THIS REPORT WAS INADVERTENTLY NOT SUBMITTED.

    Description of Event or Problem · 1

    DURING A SURGERY ON (B)(6) 2014, DR. (B)(6) REMOVED A NON-OSTEOMED CLAW PLATE PREVIOUSLY IMPLANTED. A NON-OSTEOMED TITANIUM FOAM WEDGE, ALSO IMPLANTED DURING THE PREVIOUS SURGERY, WAS VERY INTEGRATED INTO THE PATIENT. THEREFORE IT WAS ALLOWED TO REMAIN. THE PHYSICIAN CREATED A NEW WEDGE SHAPED VOID TO FURTHER LENGTHEN THE LATERAL COLUMN AND FILLED IT WITH THE OSTEOMED OSTEOVATION PRODUCT. THEN THE OSTEOMED EXTREMILOCK 2.7 "T" PLATE WAS PLACED OVER IT FOR FIXATION. THE T-PLATE BROKE POST OPERATIVELY. ON (B)(6) 2015, DR. (B)(6) REMOVED THE BROKEN OSTEOMED PLATE, AND THE NON-OSTEOMED TITANIUM FOAM WEDGE. THESE IMPLANTS WERE REPLACED WITH B-TCP BEADS (P/N 390-8012) AND A 3/5/4.0 MM - 30 MM H PLATE (PN/336-3502). THE PHYSICIAN FOLLOWED THE SURGICAL TECHNIQUE GUIDE BY "SOAKING" THE BEADS IN BMA. THE USED ONE (1) 12CC BEAD KIT. HE ALSO USED A MINI-RAIL (EXTERNAL FIXATOR) TO INCREASE THE OPPORTUNITY FOR FIXATION AND UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116351 EXTREMILOCK FOOT PLATING SYSTEM 6-HOLE T COMPRESISON PLATE HRS OSTEOMED L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention