BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6296645 · Received February 2, 2017

    Report

    Report Number
    2520274-2017-10363
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 6, 2016
    Report Date
    January 24, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN 2.4-MM VARIABLE ANGLE LOCKING COMPRESSION (LCP) VOLAR RIM DISTAL RADIUS PLATE [VRP]/UNKNOWN QUANTITY/UNKNOWN LOT. 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. (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM MEDICAL DOCTOR (MD) ON (B)(6) 2017 STATING THAT THE PLATE SITS ON THE DISTAL VOLAR RIM OF THE RADIUS AND CAN RESULT IN TENDON IRRITATION. THE PLATE AND DESIGN ARE NOT THE PROBLEM AND ITS INDICATION IS ONLY FOR VERY COMPLEX DISTAL RADIUS FRACTURES OF THE DISTAL RIM.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE KACHOOEI, A; TARABOCHIA, M AND JUPITER J. (2016). DISTAL RADIUS VOLAR RIM FRACTURE FIXATION USING DEPUY-SYNTHES VOLAR RIM PLATE. J WRIST SURG;5:2¿8. THIS STUDY, ASSESS THE RESULTS OF DISTAL RADIUS FRACTURES WITH THE INVOLVEMENT OF THE VOLAR RIM FIXED WITH THE DEPUY-SYNTHES VOLAR RIM PLATE. THE PATIENTS WITH VOLAR RIM FRACTURE AND/OR VOLAR RIM FRACTURES AS PART OF A COMPLEX FRACTURE FIXED WITH A VOLAR RIM PLATE. TEN PATIENTS MET THE INCLUSION CRITERIA: THREE PATIENTS WITH TYPE 23B3, SIX PATIENTS WITH TYPE 23C, AND ONE PATIENT WITH VERY DISTAL TYPE 23A. THE MEAN FOLLOW-UP WAS 14 MONTHS (RANGE: 2¿26). THE AVERAGE AGE OF THE PATIENTS WAS 54 YEARS (RANGE: 23¿71). NINE PATIENTS WERE WOMEN WHO SUFFERED A FALL. ONE PATIENT WAS A (B)(6) MAN WHO SUFFERED A TRAUMATIC ACCIDENT. FRACTURES HEALED IN ALL PATIENTS. OF THE THREE PATIENTS WITH ISOLATED VOLAR RIM FRACTURES (TYPE 23B3), TWO PATIENTS HAD NO DETECTABLE DEFICITS IN MOTION. THESE PATIENTS HAD AN AVERAGE GARTLAND AND WERLEY SCORE OF 9 (RANGE: 2¿14). OF THE OTHER SEVEN PATIENTS (SIX WITH TYPE 23C AND ONE WITH TYPE 23A FRACTURE), THREE PATIENTS HEALED WITH FULL RANGE OF MOTION. TWO PATIENTS HAD EXCELLENT RESULTS, THREE HAD GOOD RESULTS, AND TWO HAD FAIR RESULTS USING THE GARTLAND AND WERLEY CATEGORICAL RATING. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 2.4-MM VARIABLE ANGLE LOCKING COMPRESSION (LCP) VOLAR RIM DISTAL RADIUS PLATE [VRP] FOR ONE PATIENT WHO HEALED WITH A SHORTENED RADIUS AND ULNAR IMPINGEMENT REQUIRING A SECOND SURGERY FOR ULNAR HEAD RESECTION ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80470 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention