BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-00955

    MDR report key: 3658688 · Received March 4, 2014

    Report

    Report Number
    2520274-2014-00955
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ARTICLE: THE RESULTS OF ORIF OF DISPLACED UNSTABLE PROXIMAL HUMERAL FRACTURES USING A LOCKING PLATE; XAVIER A. DURALDE, MD, LEE R. LEDDY, MD; J SHOULDER ELBOW SURG (2010) 19, 480-488. J SHOULDER ELBOW SURG (2010) 19, 480-488. DEVICE IS AN UNKNOWN AO PLATE, QUANTITY 1. CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: THE RESULTS OF ORIF OF DISPLACED UNSTABLE PROXIMAL HUMERAL FRACTURES USING A LOCKING PLATE. SURGICAL MANAGEMENT OF DISPLACED UNSTABLE PROXIMAL HUMERUS FRACTURE REMAINS A CHALLENGE DUE TO POOR PROXIMAL BONE QUALITY AND SIGNIFICANT DEFORMING FORCES. WE HYPOTHESIZED THAT THE TECHNIQUE OF APPLICATION AND MECHANICAL PROPERTIES OF THE PROXIMAL HUMERAL LOCKING PLATE WOULD ALLOW SUCCESSFUL TREATMENT OF UNSTABLE AND DISPLACED PROXIMAL HUMERAL FRACTURES EVEN IN THE FACE OF OSTEOPOROTIC BONE. WE EVALUATED PROSPECTIVELY THE RESULTS OF OPEN REDUCTION INTERNAL FIXATION OF 22 DISPLACED UNSTABLE PROXIMAL HUMERUS FRACTURES IN 22 PATIENTS UTILIZING A PROXIMAL HUMERAL LOCKING PLATE. THE PURPOSE OF THIS STUDY IS TO EVALUATE OUR RESULTS WITH OPEN REDUCTION AND INTERNAL FIXATION UTILIZING A LOCKING PLATE IN THE MANAGEMENT OF DISPLACED AND UNSTABLE PROXIMAL HUMERUS FRACTURES AND DESCRIBE OUR OPERATIVE TECHNIQUE. BETWEEN SEPTEMBER OF 2003 AND MARCH OF 2006, ALL PATIENTS PRESENTING WITH DISPLACED UNSTABLE FRACTURES OF THE PROXIMAL HUMERUS WERE TREATED PROSPECTIVELY BY THE SENIOR AUTHOR WITH OPEN REDUCTION INTERNAL FIXATION UTILIZING A PROXIMAL HUMERAL LOCKING PLATE (AO LOCKING COMPRESSION PLATE). THERE WERE 22 PATIENTS WITH 22 FRACTURES. ONE FEMALE PATIENT WAS LOST TO FOLLOW-UP. DURING THIS TIME PERIOD, AN ADDITIONAL 20 PATIENTS WERE TREATED FOR PROXIMAL HUMERAL FRACTURES BY CLOSED METHODS AND NO PATIENT UNDERWENT HUMERAL HEAD REPLACEMENT FOR FRACTURES. OF THE REMAINING 21, THERE WERE 13 WOMEN AND 8 MEN WITH AN AVERAGE AGE OF 50 (RANGE, 28-71). FOLLOW-UP AVERAGED 37 MONTHS (RANGE, 24-60). A TOTAL OF 21 OF 22 PATIENTS WERE AVAILABLE FOR MINIMUM 2-YEAR FOLLOW-UP. THERE WERE NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS IN THIS PATIENT GROUP. SPECIFICALLY, THERE WERE NO CASES OF NERVE INJURY, INFECTIONS, HARDWARE FAILURE, LOSS OF REDUCTION, IMPINGEMENT, OR PROMINENT HARDWARE. NO ONE COMPLAINED OF HARDWARE IRRITATION AND NO HARDWARE REQUIRED REMOVAL. ALL FRACTURES HAVE GONE ON TO CLINICAL AND RADIOGRAPHIC UNION. ONE PATIENT STATUS POST ORIF (OPEN REDUCTION INTERNAL FIXATION) OF A SURGICAL NECK NONUNION WHO CONTINUED TO SMOKE REQUIRED INJECTION OF AUTOLOGOUS BONE MARROW UNDER FLUOROSCOPY AT 12 MONTHS FOR PERSISTENT RADIOLUCENCY AT THE NONUNION SITE. THIS HEALED BY 3 MONTHS LATER. NO OTHER INTERVENTIONS INCLUDING BONE STIMULATORS WERE REQUIRED. THE IMPACT OF THE MALUNIONS IN THIS SERIES WAS MINIMAL. FOUR OF THE 5 PATIENTS HAD AN EXCELLENT RESULT AND BOTH PATIENTS WITH LESSER TUBEROSITY MALUNION REACHED T10 WITH INTERNAL ROTATION. TWO PATIENTS WENT ON TO DEVELOP AVASCULAR NECROSIS BOTH AT 18 MONTHS POSTOPERATIVELY. ONE PATIENT HAD AN IMPACTED 4-PART FRACTURE AND SMOKED CIGARETTES DAILY, AND ANOTHER, A 3-PART FRACTURE/DISLOCATION. NEITHER HAS REQUIRED REVISION SURGERY AS OF WRITING, BUT BOTH HAVE A POOR RESULT. IN THE NINE 3-PART FRACTURES, THERE WERE 7 EXCELLENT AND 2 GOOD RESULTS. THERE WERE 3 POOR RESULTS IN THIS SERIES. TWO HAD HIGH ENERGY INJURIES (MOTORCYCLE) AND 2 DEVELOPED AVN POSTOPERATIVELY. ANOTHER IS A TELEPHONE TECHNICIAN WITH A 3-PART FRACTURE/ DISLOCATION WHO DEVELOPED AVN AND HAS NOT BEEN ABLE TO CLIMB POLES FOLLOWING THIS INJURY. ONE IS A YOUNG (B)(6) MALE WITH A 3-PART FRACTURE WHO OBJECTIVELY HAD A RELATIVELY GOOD RANGE OF MOTION AND STRENGTH BUT COMPLAINED OF SIGNIFICANT FUNCTIONAL LIMITATIONS. THE CONSISTENTLY SATISFACTORY RESULTS INDICATE THAT THE PROXIMAL HUMERAL LOCKING PLATE REPRESENTS AN EXCELLENT DEVICE IN THE MANAGEMENT OF DISPLACED UNSTABLE PROXIMAL HUMERAL FRACTURES. THIS REPORT IS FOR MULTIPLE REPORTABLE MALFUNCTIONS: THE IMPACT OF THE MALUNIONS IN THIS SERIES WAS MINIMAL. FOUR OF THE 5 PATIENTS HAD AN EXCELLENT RESULT AND BOTH PATIENTS WITH LESSER TUBEROSITY MALUNION REACHED T10 WITH INTERNAL ROTATION. TWO PATIENTS WENT ON TO DEVELOP AVASCULAR NECROSIS BOTH AT 18 MONTHS POSTOPERATIVELY. ONE PATIENT HAD AN IMPACTED 4-PART FRACTURE AND SMOKED CIGARETTES DAILY, AND ANOTHER, A 3-PART FRACTURE/DISLOCATION. NEITHER HAS REQUIRED REVISION SURGERY AS OF WRITING, BUT BOTH HAVE A POOR RESULT. IN THE NINE 3-PART FRACTURES, THERE WERE 7 EXCELLENT AND 2 GOOD RESULTS. THERE WERE 3 POOR RESULTS IN THIS SERIES. TWO HAD HIGH ENERGY INJURIES (MOTORCYCLE) AND 2 DEVELOPED AVN POSTOPERATIVELY. ANOTHER IS A TELEPHONE TECHNICIAN WITH A 3-PART FRACTURE/ DISLOCATION WHO DEVELOPED AVN AND HAS NOT BEEN ABLE TO CLIMB POLES FOLLOWING THIS INJURY. THIS REPORT IS FOR AN AO LOCKING COMPRESSION PLATE. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130986 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1