BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6057895 · Received October 26, 2016

    Report

    Report Number
    2520274-2016-15052
    Event Type
    Injury
    Date Received
    October 26, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. TREATMENT OF COMPLEX PROXIMAL TIBIA FRACTURES WITH THE LESS INVASIVE SKELETAL STABILIZATION SYSTEM. J ORTHOP TRAUMA, VOL 18:8, 521-527. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: RICCI, WILLIAM; RUDZKI, JONAS; BORRELLI, JOSEPH (2004) TREATMENT OF COMPLEX PROXIMAL TIBIA FRACTURES WITH THE LESS INVASIVE SKELETAL STABILIZATION SYSTEM. J ORTHOP TRAUMA, VOL 18:8, 521-527. THIS PROSPECTIVE STUDY FOR PROXIMAL TIBIA FRACTURES WITH METAPHYSEAL COMMINUTION PRESENT A DIFFICULT TREATMENT CHALLENGE. THE LESS INVASIVE SKELETAL STABILIZATION (LISS) (LISS; (B)(4)) INTERNAL FIXATOR SYSTEM HAS THEORETICAL ADVANTAGES (MINIMALLY INVASIVE FIXED ANGLE CONSTRUCT) FOR THE TREATMENT OF THESE INJURIES. THIS REPORT PRESENTS CLINICAL RESULTS OF THE LISS SYSTEM FOR TREATMENT OF COMPLEX PROXIMAL TIBIA FRACTURES AND ILLUSTRATES THE UNIQUE PROPERTIES OF THE SYSTEM. BETWEEN NOVEMBER 1998 AND JANUARY 2003, 34 CONSECUTIVE PATIENTS MET THE INCLUSION CRITERIA, 6 OF THESE PATIENTS WERE EXCLUDED; TWO DIED IN THE EARLY POSTOPERATIVE PERIOD AND FOUR WERE LOST TO FOLLOW-UP. THE REMAINING 38 PATIENTS WERE STUDIED. TWENTY-THREE OF THE PATIENTS WERE MEN AND 15 WERE WOMEN (MEAN AGE WAS 53 YEARS). TWO PATIENTS WERE TREATED WITH TEMPORARY EXTERNAL FIXATORS PRIOR TO DEFINITIVE INTERNAL FIXATION. LESS INVASIVE STABILIZATION SYSTEM PLATES AND SCREWS WERE USED IN ALL PATIENTS INCLUDING (9)5-HOLE PLATES, (21) 9-HOLE PLATES, AND (8) 13-HOLE PLATES. ALL PATIENTS HEALED THEIR FRACTURE AFTER THE INDEX PROCEDURE EXCEPT ONE. THIS PATIENT HAD IMPLANT LOOSENING EVIDENT 9 WEEKS POSTOPERATIVELY. RADIOGRAPHS REVEALED THAT THE PLATE/SCREW CONSTRUCT HAD LOOSENED FROM THE DISTAL FRAGMENT. HIS IMPLANTS WERE REMOVED ELECTIVELY, AND HE WAS TREATED WITH CAST IMMOBILIZATION FOR 4 ADDITIONAL WEEKS. THE FRACTURE UNITED WITHOUT NEED FOR FURTHER REPAIR. THERE WERE NO NONUNIONS. ONE OF THE PATIENTS WITH A TYPE 41C3 FRACTURE DEVELOPED SYMPTOMATIC POSTTRAUMATIC KNEE ARTHRITIS. SHE UNDERWENT TOTAL KNEE REPLACEMENT WITH IMPLANT REMOVAL 20 WEEKS AFTER THE INDEX PROCEDURE. COMPARTMENT SYNDROME WAS DIAGNOSED IN FOUR PATIENTS, TWO PREOPERATIVELY AND TWO AFTER LISS PLATE PLACEMENT. ALL WERE SUCCESSFULLY TREATED WITH FASCIOTOMY. TWO PATIENTS COMPLAINED OF IMPLANT-RELATED PAIN AT THE PROXIMAL PORTION OF THE PLATE. IN ONE OF THESE CASES, THE PAIN RESOLVED AFTER IMPLANT REMOVAL, AND IN THE OTHER, THE SYMPTOMS WERE NOT SEVERE ENOUGH TO WARRANT IMPLANT REMOVAL. NO OTHER PATIENTS REQUIRED REOPERATION. ONE PATIENT WAS MALALIGNED IN APEX POSTERIOR ANGULATION. THE LISS INTERNAL FIXATOR SYSTEM CAN BE USED SUCCESSFULLY TO TREAT COMPLEX PROXIMAL TIBIA FRACTURES WITHOUT THE NEED FOR ADDITIONAL MEDIAL STABILIZATION. THIS IS 2 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LISS SYSTEM AND REFERS TO THE SERIOUS INJURY/MALFUNCTION OF 1 MALE PATIENT WHO EXPERIENCED IMPLANT LOOSENING AND REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707692 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention