BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4706381 · Received April 20, 2015

    Report

    Report Number
    2520274-2015-13113
    Event Type
    Injury
    Date Received
    April 20, 2015
    Date of Event
    January 28, 2003
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS. THIS REPORT IS FOR UNKNOWN 3.5 DYNAMIC COMPRESSION PLATE. DELAYED HEALING AND BONE DEFECT. 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. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE:MARTI, R; ET AL; OPERATIVE TREATMENT OF MID-SHAFT CLAVICULAR NON-UNION; INTERNATIONAL ORTHOPAEDICS (SICOT) (2003) 27: PG. 131¿135. BETWEEN 1974 AND 1999, WE TREATED OPERATIVELY 28 PATIENTS WITH A SYMPTOMATIC MID-SHAFT CLAVICULAR NON-UNION USING AO OSTEOSYNTHESIS, INCLUDING BONE GRAFTING. NINE PATIENTS HAD A WAVE-PLATE OSTEOSYNTHESIS AND 19 A STANDARD AO/ASIF OSTEOSYNTHESIS. THE MEAN FOLLOW-UP WAS 10 (2¿25) YEARS. ALL BUT ONE NON-UNION SHOWED FULL BONY CONSOLIDATION. PRE-OPERATIVELY, BRACHIALGIA WAS PRESENT IN 12 PATIENTS. OF THESE PATIENTS, SIX WERE TREATED USING STANDARD OSTEOSYNTHESIS TECHNIQUE AND SIX BY WAVE-PLATE OSTEOSYNTHESIS. POST-OPERATIVELY, PATIENTS TREATED BY WAVE-PLATE OSTEOSYNTHESIS HAD NO BRACHIALGIA AND ALSO HAD A HIGHER CONSTANT SCORE THAN THOSE PATIENTS TREATED USING STANDARD AO/ASIF TECHNIQUES. UNION OF THE CLAVICLE OCCURRED AFTER A MEAN OF 4 (3¿7) MONTHS IN 27 PATIENTS. IN ONE CASE, A BONY CLAVICLE DEFECT PERSISTED, ALTHOUGH SYMPTOMS WERE DIMINISHED. ALL PATIENTS EXPERIENCED AN IMPROVEMENT IN FUNCTION AND LESS PAIN. BRACHIALGIA WAS PRESENT PRE-OPERATIVELY IN 12 CASES, OF WHICH SIX WERE TREATED USING STANDARD OSTEOSYNTHESIS TECHNIQUE AND SIX BY WAVE-PLATE OSTEOSYNTHESIS. POST-OPERATIVELY, ALL PATIENTS TREATED BY A WAVE-PLATE AND TWO TREATED BY STANDARD OSTEOSYNTHESIS IMPROVED (TABLE 1). HOWEVER, FOUR PATIENTS TREATED BY STANDARD OSTEOSYNTHESIS TECHNIQUES DEVELOPED BRACHIALGIA POST-OPERATIVELY. IN SIX CASES, ELECTROMYOGRAPHY REVEALED SYMPTOMS OF ULNAR NERVE DYSFUNCTION. OF EIGHT PATIENTS WITH POST-OPERATIVE BRACHIALGIA, FOUR WERE TREATED OPERATIVELY WITH RESECTION OF THE FIRST RIB. FOUR PATIENTS WERE ABLE TO COPE WITH THEIR SYMPTOMS AND REFUSED FURTHER TREATMENT. TWO PATIENTS OPERATED ON WITH WAVE-PLATE TECHNIQUE HAD A SLIGHT DELAY IN WOUND HEALING. ONE HAD A PERSISTENT NON-UNION. A RE-FRACTURE OCCURRED AFTER HEALING OF THE NONUNION AND HARDWARE REMOVAL, PRECEDED BY AN ADEQUATE TRAUMA. HEALING WAS ACHIEVED WITHIN 3 MONTHS OF RE-OSTEOSYNTHESIS. COMPLICATION: STANDARD: (N=19) AO WAVE-PLATE: (N=9). DELAY IN WOUND HEALING 0 ; 2. CLAVICLE INFECTION, OPERATIVE DRAINAGE 1 ; 2. ILIAC CREST INFECTION, OPERATIVE DRAINAGE 1; 0. BONE DEFECT, CLAVICLE 0; 1. RE-FRACTURE 0; 1. BRACHIALGIA 4; 0. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 3.5 DYNAMIC COMPRESSION PLATE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260864 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention