BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 10347020 · Received July 30, 2020

    Report

    Report Number
    8030965-2020-05509
    Event Type
    Injury
    Date Received
    July 30, 2020
    Report Date
    July 23, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS:TRAUMA /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (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. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: GARCIA-CEPEDA, I. ET AL (2020), RADIOLOGICAL RESULTS OF SURGICAL MANAGEMENT OF FRACTURE OF THE DISTAL RADIUS TREATED WITH VOLAR LOCKING PLATES, INJURY, VOL. 51, SUPPLEMENT 1, PAGES 542-547 (SPAIN). THE OBJECTIVE OF THIS STUDY IS TO ASSESS FUNCTIONAL AND RADIOLOGICAL RESULTS OF ALL DISTAL RADIUS FRACTURES TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION WITH A VOLAR LOCKING PLATE. THE AIM OF THE STUDY INCLUDES THE COMPARISON OF THE FUNCTIONAL RESULTS (BASED ON RANGE OF MOTION), SURGERY TIM- ING, FRACTURE/PATIENT CHARACTERISTICS AND POSTOPERATIVE RADIOLOGICAL PARAMETERS. BETWEEN JANUARY 2010 TI JUNE 2018, A TOTAL OF 170 PATIENTS WITH A MEAN AGE OF 55.9 YEARS UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION. THE IMPLANTS USED WERE A VARIABLE ANGLE LCP VOLAR RIM DISTAL RADIUS PLATE®(DEPUY-SYNTHES, SYNTHES (B)(4), OBERDORF, SWITZERLAND) FOR 5 CASES, A VARIABLE ANGLE LCP TWO-COLUMN VOLAR DISTAL RADIUS PLATE®(DEPUY-SYNTHES, SYNTHES (B)(4), OBERDORF, SWITZERLAND) FOR 107 CASES, AN ACU-LOC 2 VDR®(ACUMED LLC, HILLSBORO, OREGON, USA) FOR 50 CASES, AND A DVR CROSSLOC PLATE (BIOMET ORTHO- PEDICS, WARSAW, INDIANA, USA) FOR 8 CASES. THE ARTICLE DID NOT SPECIFY WHICH OF THE DEVICES WERE BEING USED TO CAPTURE THE FOLLOWING COMPLICATIONS: PATIENTS BELOW (B)(6) YEARS OLD HAD 0.1% FAIR AND 0.1% POOR RESULTS PATIENTS ABOVE (B)(6) YEARS OLD HAD 10.52% FAIR AND 3.9% POOR RESULTS 11 PATIENTS HAD COMPLEX REGIONAL PAIN SYNDROME. 10 PATIENTS HAD INTRA-ARTICULAR SCREW PENETRATION. 5 PATIENTS HAD TENDINOUS RUPTURE. 3 PATIENTS HAD A RUPTURE OF EXTENSOR POLLICIS LONGUS. 2 PATIENTS HAD A RUPTURE OF THE EXTENSOR DIGITORUM OF THE 2ND FINGER. 5 PATIENTS HAD PAINFUL OR HYPERTROPHIC SCARS. 3 PATIENTS HAD PAINFUL ULNAR IMPINGEMENT. 1 PATIENT HAD PAIN RELATED TO OSTEOSYNTHESIS HARDWARE. 1 PATIENT HAD STIFFNESS. 1 PATIENT HAD ULNAR NERVE COMPRESSION. 18 PATIENTS NEEDED A NEW SURGERY. 11 PATIENTS HAD HARDWARE REMOVAL. 4 PATIENTS HAD TENDINOUS DISRUPTIONS REPAIRS OR TRANSFERS. 1 PATIENT HAD NEW OSTEOSYNTHESIS. PATIENTS UNDERGOING REINTERVENTION HAD WORSE FUNCTIONAL OUTCOMES WITH A DECREASED RANGE OF MOTION IN FLEXION-EXTENSION. 2 PATIENTS HAD A FAIR RESULT FOR PALMAR TINT. 31 PATIENTS HAD A POOR RESULT FOR PALMAR TINT. 9 PATIENTS HAD FAIR RESULTS FOR RADIAL INCLINATION. 4 PATIENTS HAD POOR RESULTS FOR RADIAL INCLINATION. THIS REPORT INVOLVES UNKNOWN SCREWS: TRAUMA. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807592 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention