BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6298274 · Received February 2, 2017

    Report

    Report Number
    2520274-2017-10364
    Event Type
    Injury
    Date Received
    February 2, 2017
    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

    DATE OF EVENT: SMET, A AND EL AL. (2016). DORSAL APPROACH AND INTERNAL FIXATION OF IMPACTED INTRA-ARTICULAR DISTAL RADIUS FRACTURES WITH 2.4 MM LOCKING PLATES. HAND SURGERY AND REHABILITATION 35, 203¿209. THIS REPORT IS FOR UNKNOWN TWO (2) TITANIUM VARIABLE ANGLE 2.4 MM PLATES (2.4 MM LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM)/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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE DESMET, A AND EL AL. (2016). DORSAL APPROACH AND INTERNAL FIXATION OF IMPACTED INTRA-ARTICULAR DISTAL RADIUS FRACTURES WITH 2.4 MM LOCKING PLATES. HAND SURGERY AND REHABILITATION 35, 203¿209. THE PURPOSE OF THIS NON-COMPARATIVE, RETROSPECTIVE STUDY WAS TO DOCUMENT THE MEDIUM TERM RESULTS AFTER OPEN REDUCTION AND INTERNAL FIXATION (ORIF) THROUGH A DORSAL APPROACH OF COMMINUTED INTRA-ARTICULAR IMPACTED FRACTURES THAT HAVE LITTLE VOLAR INVOLVEMENT. THE GOAL WAS TO DETERMINE IF IT WAS JUSTIFIED TO CONTINUE INCLUDING THIS SURGICAL TECHNIQUE IN THE TREATMENT ARSENAL FOR THESE SPECIFIC INTRA-ARTICULAR WRIST FRACTURES. THIS WAS A RETROSPECTIVE, OBSERVATIONAL STUDY OF 26 PATIENTS OPERATED BETWEEN 2008 AND 2012 WHO WERE REVIEWED IN SEPTEMBER 2013. IN THE SURGICAL PROCEDURE, A SINGLE DORSAL INCISION WAS MADE OVER THE DISTAL RADIUS AND ARTHROTOMY PERFORMED. THE FRACTURE SITE WAS STABILIZED WITH TWO TITANIUM VARIABLE ANGLE 2.4 MM PLATES (2.4 MM LCP DISTAL RADIUS SYSTEM, DEPUY SYNTHESTM). THE FIRST PLATE WAS ALIGNED SO AS TO FIX THE ULNAR COLUMN OF THE DISTAL RADIUS, AND THE SECOND WAS PLACED BETWEEN THE 1ST AND 2ND EXTENSOR COMPARTMENTS TO SECURE THE RADIAL COLUMN OF THE DISTAL RADIUS. THE AVERAGE FOLLOW-UP WAS 39 MONTHS. THERE WERE 10 WOMEN AND 16 MEN WITH AN AVERAGE AGE OF 53 YEARS (+/- 14.33). ALL FRACTURES WERE TYPE 23C IN THE AO CLASSIFICATION. ALL PATIENTS WERE ASSESSED WITH THE QUICKDASH AND MAYO WRIST SCORES. TOTAL RANGE OF MOTION WAS 82% OF THE CONTRALATERAL SIDE. GRIP STRENGTH WAS 30 KG IN AVERAGE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN TWO (2) TITANIUM VARIABLE ANGLE 2.4 MM PLATES (2.4 MM LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM) AND REFERS TO FOUR PATIENTS WHO DEVELOPED SYMPTOMATIC EARLY OSTEOARTHRITIS, THIRTEEN PATIENTS WHO HAD THE PLATE REMOVED DUE TO DISCOMFORT, THIRTEEN PATIENTS (50%) WHO HAD THE PLATE AND SCREWS REMOVED AN AVERAGE OF 9 MONTHS (+/-3.66) LATER,TWO OF THESE PATIENTS (15%) HAD TENOSYNOVITIS THAT WAS DOCUMENTED WITH ULTRASONOGRAPHY AND SUBCHONDRAL SCLEROSIS IN THE RADIOCARPAL JOINT, JOINT SPACE NARROWING AND OSTEOPHYTES WERE THE MAIN FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79350 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention