BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMED STRAIGHT PLATES, "L" PLATES, "Y" PLATES

    MDR report key: 3296042 · Received August 8, 2013

    Report

    Report Number
    2027754-2013-00007
    Event Type
    Injury
    Date Received
    August 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    August 7, 2013
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OSTEOMED HAS NOT RECEIVED ANY COMPLAINTS REGARDING BREAKAGE OF ANY OF THE COMPLAINT PART NUMBERS: 210-0030 25MM 4 HOLE STRAIGHT PLATE; 210-0016 23MM LEFT "L" PLATE; 210-0018 26MM "Y" PLATE; OR 210-0032 10 HOLE STRAIGHT PLATE. IN ADDITION, BASED ON THE LOT NUMBERS OF THE PLATES PROVIDED, ALL THE PLATES MEET THE RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED BREAKAGE OF THE PLATES WAS NOT DETERMINED. NO X-RAYS WERE PROVIDED AND THE BROKEN PLATES HAVE NOT BEEN RECEIVED FOR ANALYSIS AND VERIFICATION THAT THE PLATES WERE BROKEN EVEN THOUGH A RETURN NUMBER WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED BY OSTEOMED VIA THE DISTRIBUTOR TO THE DOCTOR HAS ALSO NOT BEEN RECEIVED. PER THE DISTRIBUTOR, ON (B)(6) 2013, DUE TO THE HOLIDAYS, IT MAY TAKE A WHILE UNTIL THE INFORMATION REQUESTED BY OSTEOMED FROM THE DOCTOR IS RECEIVED. IF THE PLATES ARE RECEIVED, OR ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PT RECOVERY WAS NOT AS EXPECTED BECAUSE THE LEFORT PLATES DID NOT CONSOLIDATE. THE PT UNDERWENT SURGERY IN (B)(6) 2012 TO IMPLANT FOUR LEFORT PLATES. A WEEK AFTER SURGERY, THE PT FELT THERE WAS MOVEMENT AND AN X-RAY SHOWED THE FOUR PLATES WERE BROKEN. A SECOND SURGERY WAS PERFORMED IN (B)(6) 2013 TO REMOVE THE PLATES AND PUT IN NEW OSTEOMED PLATES. A THIRD SURGERY WAS PERFORMED IN (B)(6) 2013 WHERE THE DOCTOR CHECKED EVERYTHING AND REMOVED SOME TISSUE TO DISMISS THE POSSIBILITY OF NECROSIS. THE PLATES IMPLANTED DURING THE SECOND SURGERY WERE NOT REMOVED. THE PT SEEMS TO BE OK BUT ACCORDING TO THE INFORMATION RECEIVED FROM THE DISTRIBUTOR, THE RESULTS OF THE SURGERY STILL LOOKED BAD. A FOURTH SURGERY IS EXPECTED BUT HAS NOT BEEN PERFORMED. A RESPONSE HAS NOT BEEN RECEIVED FROM THE DOCTOR ON WHY HE FEELS THAT A FOURTH SURGERY MAY BE REQUIRED. THERE WERE NO INDICATIONS THAT ANYTHING WENT WRONG WITH THE SECOND SET OF OSTEOMED PLATES WHICH WERE IMPLANTED IN (B)(6) 2013. PLATE: 210-0030 24MM 4 HOLE STRAIGHT PLATE LOT 1028110; 210-0016 23MM LEFT "L" PLATE LOT 1022431; 210-0018 26MM "Y" PLATE LOT 1000547; 210-0032 10 HOLE STRAIGHT PLATE LOT 1034638.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375748 OSTEOMED STRAIGHT PLATES, "L" PLATES, "Y" PLATES NONE HRS 1028110; 1022431

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention