BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5364151 · Received January 13, 2016

    Report

    Report Number
    2520274-2016-10112
    Event Type
    Injury
    Date Received
    January 13, 2016
    Report Date
    January 5, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SANCHEZ-SOTELO, J., MD, PHD, TORCHIA, M.E., MD, AND O¿DRISCOLL, S.W., PHD, MD (2007). COMPLEX DISTAL HUMERAL FRACTURES: INTERNAL FIXATION WITH A PRINCIPLE-BASED PARALLEL-PLATE TECHNIQUE. J BONE JOINT SURG AM. 89(5), 961-969. THIS REPORT IS FOR AN UNKNOWN PELVIC RECONSTRUCTION PLATE. (B)(4): DEGENERATIVE CHANGES AND LOCALIZED COLLAPSE OF A PORTION OF THE ARTICULAR SURFACE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 JOURNAL ARTICLE, SANCHEZ-SOTELO, J., MD, PHD, TORCHIA, M.E., MD, AND O'DRISCOLL, S.W., PHD, MD (2007). COMPLEX DISTAL HUMERAL FRACTURES: INTERNAL FIXATION WITH A PRINCIPLE-BASED PARALLEL-PLATE TECHNIQUE. J BONE JOINT SURG AM. 89(5), 961-969. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE SURGICAL TECHNIQUE THAT WE USE FOR FIXATION OF FRACTURES OF THE DISTAL PART OF THE HUMERUS AND TO DEMONSTRATE ITS EFFICACY IN PROVIDING AND MAINTAINING FRACTURE STABILITY. THE AUTHORS RETROSPECTIVELY REVIEWED THE RESULTS OF THIS PRINCIPLE-BASED INTERNAL FIXATION TECHNIQUE IN A CONSECUTIVE SERIES OF DISTAL HUMERAL FRACTURES COMPLICATED BY SEVERE COMMINUTION, BONE LOSS, AND/OR OSTEOPENIA. THERE WERE NINETEEN MALE PATIENTS AND FOURTEEN FEMALE PATIENTS WITH AN AVERAGE AGE AT THE TIME OF THE SURGERY OF FIFTY-EIGHT YEARS (RANGE, SIXTEEN TO NINETY-NINE YEARS). THE LATERAL COLUMN WAS FIXED WITH A SYNTHES PELVIC RECONSTRUCTION PLATE IN TWO CASES. THE MEDIAL COLUMN WAS FIXED WITH A PELVIC RECONSTRUCTION PLATE IN TWENTY-SIX CASES. TWO ELDERLY PATIENTS ((B)(6)) WITH ASSOCIATED INTERTROCHANTERIC FRACTURES DIED TWENTY-NINE AND FOURTEEN DAYS AFTER FRACTURE FIXATION AS A RESULT OF MASSIVE PULMONARY EMBOLISM AND RESPIRATORY FAILURE, RESPECTIVELY. AT THE TIME OF THE MOST RECENT FOLLOW-UP, SEVENTEEN ELBOWS WERE NOT PAINFUL, ELEVEN WERE MILDLY PAINFUL, AND FOUR WERE MODERATELY PAINFUL. MODERATE INSTABILITY WAS PRESENT IN ONE PATIENT WITH POSTTRAUMATIC ARTHRITIS, IN ONE FOLLOWING EXCISION OF HETEROTOPIC OSSIFICATION AND A CAPSULAR RELEASE, AND IN A THIRD PATIENT IN WHOM A DEEP INFECTION HAD DEVELOPED AFTER EXCISION OF HETEROTOPIC OSSIFICATION AND OSSEOUS ANKYLOSIS. UNION OF THIRTY-ONE FRACTURES WAS ACHIEVED PRIMARILY, AND ONE FRACTURE UNITED AFTER ONE ADDITIONAL PROCEDURE CONSISTING OF BONE-GRAFTING AND FIXATION. HETEROTOPIC OSSIFICATION DEVELOPED IN TWELVE ELBOWS (38%). THE HETEROTOPIC OSSIFICATION WAS SEVERE AND REQUIRED SURGICAL EXCISION TO RESTORE MOTION IN FIVE ELBOWS. RADIOGRAPHICALLY, MODERATE DEGENERATIVE CHANGES WERE SEEN IN ONE ELBOW AND SEVERE CHANGES WERE SEEN IN ONE. TWO ELBOWS, INCLUDING THE ONE THAT HAD A DEEP INFECTION, HAD LOCALIZED COLLAPSE OF A PORTION OF THE ARTICULAR SURFACE. COMPLICATIONS REQUIRING A REOPERATION OCCURRED IN NINE ADDITIONAL PATIENTS. TWO PATIENTS UNDERWENT A REOPERATION FOR THE TREATMENT OF WOUND-HEALING COMPLICATIONS, AND ONE HAD A SURGICAL DEBRIDEMENT TO TREAT A DEEP INFECTION. FIVE PATIENTS UNDERWENT EXCISION OF SEVERE HETEROTOPIC OSSIFICATION. A REOPERATION WAS ALSO NECESSARY TO TREAT A NONUNION IN ONE PATIENT THREE AND A HALF YEARS POSTOPERATIVELY, AND THIS PROCEDURE RESULTED IN UNION. TWO ADDITIONAL PATIENTS HAD PERMANENT ULNAR NEUROPATHIES, WHICH WERE NOT TREATED SURGICALLY. FINALLY, POSTTRAUMATIC OSTEOARTHRITIS DEVELOPED IN TWO PATIENTS, AND OSTEONECROSIS DEVELOPED IN ONE. THIS REPORT IS FOR AN UNKNOWN PELVIC RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22528 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention