BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3894952 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-11919
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    April 16, 2013
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: LITERATURE CITATION: SCHLIEMANN, B. ET AL: SURGICAL TREATMENT OF VERTICALLY UNSTABLE LATERAL CLAVICLE FRACTURES (NEER 2B) WITH LOCKED PLATE FIXATION AND CORACOCLAVICULAR (CC) LIGAMENT RECONSTRUCTION PUBLISHED IN ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2013) 133:935-939. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR AN UNKNOWN QTY OF A 3.5MM T-PLATE. (B)(4). 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.

    Description of Event or Problem · 1

    LITERATURE: THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE BY SCHLIEMANN, B. ET AL: SURGICAL TREATMENT OF VERTICALLY UNSTABLE LATERAL CLAVICLE FRACTURES (NEER 2B) WITH LOCKED PLATE FIXATION AND CORACOCLAVICULAR (CC) LIGAMENT RECONSTRUCTION PUBLISHED IN ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY (2013) 133:935-939. THE ARTICLE REVIEWED A STUDY THAT EVALUATED THE OUTCOME OF PATIENTS TREATED WITH A COMBINATION OF LOCKED PLATE FIXATION AND MINIMAL-INVASIVE CORACOCLAVICULAR LIGAMENT RECONSTRUCTION FOR UNSTABLE LATERAL CLAVICLE FRACTURES. THE TYPE OF FRACTURE INVOLVED DISPLACEMENT OF THE MEDIAL FRAGMENT ( NEER CLASSIFICATION TYPE IIB). BETWEEN JANUARY 2007 AND DECEMBER 2010, 14 PATIENTS (12 MALE, 2 FEMALE) WITH AN ISOLATED UNSTABLE LATERAL CLAVICLE FRACTURE WERE TREATED WITH A COMBINATION OF LOCKED PLATE FIXATION AND A MINIMAL-INVASIVE CC LIGAMENT RECONSTRUCTION; ALL INJURIES WERE CAUSED BY A FALL ON THE AFFECTED SHOULDER, SIX OF WHICH OCCURRED WHILE PLAYING SPORTS. THE AVERAGE AGE WHEN THE INJURY OCCURRED WAS 38 YEARS, RANGING 22¿54 YEARS. FRACTURE FIXATION WAS ACCOMPLISHED WITH EITHER A 3.5 MM T-PLATE (N = 7), ORIGINALLY DESIGNED FOR DISTAL RADIUS FRACTURES, OR A PRE-SHAPED 3.5 MM LOCKING COMPRESSION PLATE (LCP) SUPERIOR LATERAL CLAVICLE PLATE (N=7) (BOTH SYNTHES, (B)(4)). AFTER FRACTURE FIXATION, VARIOUS PARTS (OTHER MANUFACTURER) WERE UTILIZED TO ASSEMBLE A SUTURE (OTHER MANUFACTURER), IN WHICH THE ENDS WERE KNOTTED OVER THE PLATE. ANATOMIC REDUCTION WAS CONTROLLED WITH INTRAOPERATIVE FLUOROSCOPY. (B)(4) IS FOR COMPLAINTS ASSOCIATED WITH TWO UNKNOWN PLATE IMPLANTS (3.5 MM T-PLATE AND A PRE-SHAPED 3.5 MM LOCKING COMPRESSION PLATE (LCP) SUPERIOR LATERAL CLAVICLE PLATE ) AND ARE NOTED AS FOLLOWS: ¿TAUTNESS¿ OVER ACROMIOCLAVICULAR (AC) JOINT AND MILD PRESSURE PAIN (N=2). CC LIGAMENT CALCIFICATIONS (N=3). PLATE REMOVAL (N=7) DUE TO IMPLANT-RELATED IRRITATION OVER THE LATERAL CLAVICLE (N=3) OR ON PATIENT¿S REQUEST (N=NOT SPECIFIED). OBVIOUS IMMINENT SKIN PERFORATION OF A PRE-SHAPED LCP (N=1); PATIENT PAIN FREE, FREE RANGE OF MOTION AND REFUSED TO HAVE THE PLATE REMOVED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370707 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention