BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6298334 · Received February 2, 2017

    Report

    Report Number
    2520274-2017-10365
    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: NAVARRO, C; AHRENGART, L; TÖRNQVIST, H AND PONZER, S. (2016). VOLAR LOCKING PLATE OR EXTERNAL FIXATION WITH OPTIONAL ADDITION OF K-WIRES FOR DORSALLY DISPLACED DISTAL RADIUS FRACTURES: A RANDOMIZED CONTROLLED STUDY. J ORTHOP TRAUMA ; 30:217¿224. THIS REPORT IS FORUNKNOWN 2.4-MM VARIABLE ANGLE LOCKING COMPRESSION (LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE /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 NAVARRO, C; AHRENGART, L; TÖRNQVIST, H AND PONZER, S. (2016). VOLAR LOCKING PLATE OR EXTERNAL FIXATION WITH OPTIONAL ADDITION OF K-WIRES FOR DORSALLY DISPLACED DISTAL RADIUS FRACTURES: A RANDOMIZED CONTROLLED STUDY. J ORTHOP TRAUMA ; 30:217¿224. THE AIM OF THIS RANDOMIZED CONTROLLED TRIAL (RCT) WAS TO INVESTIGATE WHETHER THE CLINICAL RESULT AS EVALUATED BY THE DISABILITY OF THE ARM, SHOULDER, AND HAND (DASH) AFTER VOLAR PLATING IS SUPERIOR TO THAT AFTER EXTERNAL FIXATION, WITH THE OPTIONAL ADDITION OF K-WIRES, IN A POPULATION AGED (50¿74) YEARS, WHO HAVE SUSTAINED A DORSALLY DISPLACED DISTAL RADIUS FRACTURE AFTER LOW-ENERGY TRAUMA. ONE HUNDRED FORTY PATIENTS PRESENTING WITH A DORSALLY DISPLACED DISTAL RADIUS FRACTURE WERE RANDOMIZED TO FIXATION WITH A VOLAR LOCKING PLATE (N = 70) OR EXTERNAL FIXATION WITH OPTIONAL ADDITION OF K-WIRES (N = 70). THE PRIMARY OUTCOME WAS THE DISABILITY OF THE ARM, SHOULDER, AND HAND (DASH) AT 12 MONTHS. EUROQOL-5D, RADIOGRAPHY, AND RECORDINGS OF COMPLICATIONS WERE PERFORMED AT 2 AND 6 WEEKS AND AT 3 AND 12 MONTHS. PATIENTS WERE INVESTIGATED FOR DASH, THE PATIENT-RATED WRIST EVALUATION, RANGE OF MOTION, AND GRIP STRENGTH AT 3 AND 12 MONTHS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 2.4-MM VARIABLE ANGLE LOCKING COMPRESSION (LCP) TWO-COLUMN VOLAR DISTAL RADIUS PLATE AND REFERS TO DISPLACEMENT OF THE FRACTURE REQUIRING REOPERATION IN 2 PATIENTS, ONE PATIENT HAD CARPAL TUNNEL RELEASE, 7 OUT OF 69 PATIENTS HAD THEIR PLATE REMOVED WITHIN 1 YEAR AFTER SURGERY, ALL OF WHOM PRESENTED WITH TENOSYNOVITIS BEFORE EXTRACTION, ONE PATIENT IN THE PLATE GROUP HAD A RUPTURE OF THE EXTENSOR POLLICIS LONGUS TENDON AND WAS TREATED WITH A TENDON TRANSFER, TWENTY-FOUR PATIENTS HAD DYSFUNCTION OF THE MEDIAN OR RADIAL NERVES, SEVEN OUT OF 69 PATIENTS REPORTED REMAINING DYSESTHESIA IN THE MEDIAN NERVE AT 1-YEAR FOLLOW-UP, SIGNS OF COMPLEX REGIONAL PAIN SYNDROME (CRPS) WERE PRESENT IN 3 PATIENTS AND ONE PATIENT HAD VOLAR TENOSYNOVITIS IN THIS CASE, THE FRACTURE HAD DISPLACED DORSALLY WHICH LEFT THE PLATE PROTRUDING VOLARLY, WITH A RADIOGRAPHIC PICTURE MAKING IMPINGEMENT OF TENDONS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79741 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention