BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4841168 · Received June 12, 2015

    Report

    Report Number
    2520274-2015-14409
    Event Type
    Injury
    Date Received
    June 12, 2015
    Report Date
    June 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GALLAGHER, C.A., BLAKENEY, W., AND ZELLWEGER, R. (2014). ACROMIOCLAVICULAR JOINT DISLOCATION WITH ASSOCIATED BRACHIAL PLEXUS INJURY. BMJ CASE REP. PUBLISHED ONLINE: DOI:10.1136/BCR-2013-203299. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. 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, GALLAGHER, C.A., BLAKENEY, W., AND ZELLWEGER, R. (2014). ACROMIOCLAVICULAR JOINT DISLOCATION WITH ASSOCIATED BRACHIAL PLEXUS INJURY. BMJ CASE REP. PUBLISHED ONLINE: DOI:10.1136/BCR-2013-203299. THE AUTHORS PRESENTED THE CASE OF A (B)(6) FEMALE WHO SUSTAINED A LEFT ACROMIOCLAVICULAR (AC) JOINT TYPE V INJURY AND BRACHIAL PLEXUS INJURY. THE PATIENT¿S AC JOINT INJURY WAS IDENTIFIED 6 DAYS AFTER SHE WAS INVOLVED IN A MOTORBIKE ACCIDENT WHERE SHE SUSTAINED MULTIPLE OTHER INJURIES. PLAIN RADIOGRAPHS REVEALED A TYPE V AC JOINT DISLOCATION. ORTHOPAEDIC SURGERY WAS INITIALLY DELAYED DUE TO HER OTHER INJURIES. IT WAS FELT THAT A PARTICULARLY STRONG PLATE WAS REQUIRED AND A SYNTHES FOUR-HOLE RIGHT LOCKING COMPRESSION MEDIAL PROXIMAL TIBIAL PLATE WAS CHOSEN AS THE MOST APPROPRIATE FORM OF FIXATION. AT THE 3-MONTH FOLLOW-UP FROM THE DATE OF INJURY, THE PATIENT WAS FOUND TO HAVE A SUBLUXED LEFT SHOULDER. IN ADDITION THE TIBIAL PLATE HAD CUT OUT. EXAMINATION AT THE TIME REVEALED DELTOID ATROPHY, SENSORY CHANGE IN THE AXILLARY NERVE DISTRIBUTION, AND MOTOR WEAKNESS WITH SHOULDER ABDUCTION 1/5, ELBOW FLEXION 3/5 AND ELBOW EXTENSION 3/5. ELECTROMYOGRAPHY WAS PERFORMED WHICH DEMONSTRATED AXONAL INJURY TO THE UPPER TRUNK OF THE LEFT BRACHIAL PLEXUS WITH EVIDENCE OF ON-GOING RE-INNERVATION. THE PLATE WAS SUBSEQUENTLY REMOVED AND THE AC JOINT WAS FOUND TO BE STABLE INTRA-OPERATIVELY. PHYSIOTHERAPY WAS COMMENCED TO IMPROVE MUSCLE STRENGTH AND RANGE OF MOTION. STRENGTH AND SENSATION GRADUALLY RETURNED. AT 12 MONTHS POST-INJURY, THE PATIENT WAS PAIN FREE AND COULD COMPLETE ALL HER ACTIVITIES OF DAILY LIVING WITHOUT IMPEDIMENT. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384575 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention