BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLATE

    MDR report key: 2350552 · Received February 6, 2012

    Report

    Report Number
    2520274-2011-00734
    Event Type
    Other
    Date Received
    February 6, 2012
    Report Date
    October 27, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS PRODUCT IS BEGINNING EVAL.

    Additional Manufacturer Narrative · 1

    THE ACTUAL PART NUMBER OF THIS PLATE IS UNKNOWN. ALTHOUGH IT CAN NOT BE POSITIVELY IDENTIFIED, RESEARCH INTO THE PLATE HAS DETERMINED IT TO BE ONE OF THE TITANIUM MATRIXRIB PRE-CONTOURED PLATES FOR THE RIGHT RIBS, PART NUMBER 04.501.00X. AS RECEIVED, THIS PLATE HAS BEEN SHORTENED TO A NINE HOLE PLATE, HAVING BEEN CUT AFTER THE NINTH HOLE FROM THE END OF THE PLATE THAT DOES NOT GET LASER ETCHED. THE PLATE IS RADIUSED UP AT APPROXIMATELY A R250 FROM THE END OF THE PLATE THROUGH THE SIXTH HOLE FROM THE END, WHERE THE REMAINING 3 HOLES ARE RADIUSED UP SIGNIFICANTLY MORE AT APPROXIMATELY AN R50. THE FOUR HOLES CLOSEST TO THE CUT EACH HAVE DENTS / NICKS ON THE PERIMETER OF THE HOLES, WITH SOME SLIGHT MATERIAL ENCROACHING INTO THE BALL HOLE RADIUS. THE ANODIZING HAS BEEN COMPLETELY RUBBED OFF THE EDGE OF THE PLATE AT THE THIRD HOLE FROM THE CUT. THIS RUBBING CAN ALSO BE SEEN ON THE PLATE EDGE AT THE TWO ADJACENT HOLES, BUT ONLY IN A SMALL AREA CLOSEST TO THE THIRD HOLE. NO OTHER VISUAL ANOMALIES WERE NOTICED THE THREADS HAVE BEEN CHECKED WITH A MATRIXRIB LOCKING SCREW; LOCKING AND UNLOCKING PROCEDURE WAS STILL POSSIBLE. IT IS UNCLEAR FROM THE DESCRIPTION IF ADEQUATE REDUCTION OF THE RIB FRACTURE WAS ACHIEVED DURING IMPLANTATION. IN SITUATIONS OF NON-UNION, REMOVAL OF NONVIABLE BONE AND FULL REDUCTION OF THE FRACTURE SEGMENTS ARE REQUIRED IF THIS IS NOT DONE, DELAYED OR NON-UNION COULD RESULT AFTER PLATING. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PT WITH AN OLD FRACTURE IN THE RIB (2006) WAS EXPERIENCING A GREAT DEAL OF PAIN AND WAS IMPLANTED WITH A RIGHT RIB PLATE ABOUT A MONTH AGO. THE PT RETURNED TO THE SURGEON COMPLAINING HE WAS STILL IN A LOT OF PAIN AND COULD HEAR "CLICKING" SOUNDS. AN X-RAY WAS TAKEN ON AN UNK DATE AND SHOWED THREE SCREWS ON ONE SIDE OF THE PLATE WERE SOLID, TWO SCREWS ON THE OTHER SIDE OF THE PLATE WERE STILL IN THE PLATE BUT THE PLATE WAS RAISED UP OFF THE BONE, AND A THIRD SCREW WAS UNDER THE PLATE ("FREE FLOATING"). THE PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2011. THE SURGEON REMOVED THE PLATE AND ALL THE SCREWS, PLACED A NEW PLATE AND RE-USED 5 OF THE 6 SCREWS JUST REMOVED. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male SCREW| PLATE