BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3985992 · Received August 6, 2014

    Report

    Report Number
    2520274-2014-12576
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN 2.4 MILLIMETER VOLAR LOCKING PLATE. (B)(4), IS FOR CARPAL TUNNEL RELEASE, EXCISION OF A GANGLION OF THE EXTENSOR POLLICUS LONGUS AND RADIOCARPAL ARTHROSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, SOUER, J.S. ET AL. (2011). COMPARISON OF INTRA-ARTICULAR SIMPLE COMPRESSION AND EXTRA-ARTICULAR DISTAL RADIAL FRACTURES. THE JOURNAL OF BONE AND JOINT SURGERY, 93, 2093-2099. THE AUTHORS TESTED THE HYPOTHESIS THAT WRIST MOTION AND FUNCTION SCORES WOULD NOT DIFFER BETWEEN PATIENTS WITH AN EXTRA-ARTICULAR FRACTURE AND THOSE WITH A SINGLE SAGITTAL INTRA-ARTICULAR FRACTURE FOLLOWING OPEN FRACTURE REDUCTION AND INTERNAL FIXATION WITH THE USE OF A VOLAR LOCKING PLATE. OPEN REDUCTION INTERNAL FIXATION WAS PERFORMED IN 37 PATIENTS WITH A SINGLE INTRA-ARTICULAR FRACTURE, 31 WOMEN AND SIX MEN, WITH AVERAGE AGE OF 56 YEARS (RANGE, 21-79 YEARS). THERE WERE THREE GROUPS OF TREATED PATIENTS: 12 WITH SYNTHES 2.4 MILLIMETER VOLAR LOCKING PLATE, AND 12 AND FOUR WITH PLATES OF TWO OTHER MANUFACTURERS. THE AUTHORS REPORTED: IRRITATION OF THE VOLAR PLATE REQUIRING REMOVAL (TWO); ULNAR NERVE IRRITATION (ONE); TENDON ADHESION TREATED WITH TENOLYSIS AND CARPAL TUNNEL RELEASE (ONE); DISPROPORTIONATE PAIN AND DISABILITY (TWO), ONE OF WHOM EXPERIENCED LOSS OF REDUCTION OF THE VOLAR LUNATE FACET TREATED WITH A SECOND SURGICAL PROCEDURE THAT WAS NOT SUCCESSFUL IN MAINTAINING REALIGNMENT OF THE LUNATE FACET. ARTICULAR STEP-OFF WAS REPORTED IN FOUR PATIENTS AT THE TIME OF FINAL FOLLOW-UP; 14 HAD SIGNS OF RADIOCARPAL ARTHROSIS. THERE WERE 74 PATIENTS (62 WOMEN AND 12 MEN) WITH AN EXTRA-ARTICULAR FRACTURE. AVERAGE AGE WAS 56 YEARS (RANGE, 21-79 YEARS). OPEN REDUCTION INTERNAL FIXATION WAS PERFORMED IN THREE GROUPS: 30 WITH SYNTHES PLATE, AND 37 AND 7 WITH PLATES OF TWO OTHER MANUFACTURERS. THE AUTHORS REPORTED: EXTENSION DEFICIT (ONE); EXTENSOR POLLICIS LONGUS TENDON RUPTURE (ONE); NUMBNESS AT THE BASE OF THE THUMB (ONE); SUPERFICIAL INFECTION TREATED WITH OPERATIVE DEBRIDEMENT (ONE); PLATE IRRITATION (FOUR) TWO OF WHOM UNDERWENT IMPLANT REMOVAL; CARPAL TUNNEL SYNDROME RELEASE (THREE); REGIONAL PAIN SYNDROME (TWO); AND EXCISION OF A GANGLION OF THE EXTENSOR POLLICUS LONGUS (ONE). RADIOCARPAL ARTHROSIS WAS REPORTED IN SIX. THE AUTHORS DID NOT SPECIFY WHICH EVENT WAS ASSOCIATED WITH A SPECIFIC DEVICE. THIS REPORT IS FOR AN UNKNOWN 2.4 MILLIMETER VOLAR LOCKING PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461067 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention