BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10345143 · Received July 30, 2020

    Report

    Report Number
    8030965-2020-05483
    Event Type
    Injury
    Date Received
    July 30, 2020
    Report Date
    July 21, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PLATE/SCREWS/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. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SA-NGASOONGSONG, P. ET AL. (2020), COMPARISON OF FRACTURE HEALING AND LONG-TERM PATIENT-REPORTED FUNCTIONAL OUTCOME BETWEEN DORSAL AND VOLAR PLATING FOR AO C3-TYPE DISTAL RADIUS FRACTURES, EUROPEAN JOURNAL OF TRAUMA AND EMERGENCY SURGERY, VOL 46, PAGES 591-598 (SWITZERLAND). THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE LONG-TERM FUNCTIONAL OUTCOME BETWEEN DORSAL AND VOLAR LOCKING PLATE FIXATION IN PATIENTS WITH AN INTRA-ARTICULAR COMMINUTED DISTAL RADIUS FRACTURES DRF (AO C3 TYPE). A SECONDARY OUTCOME WAS TO EVALUATE THE RADIOGRAPHIC FRACTURE HEALING AND DIFFERENCES IN RADIOGRAPHIC MEASUREMENT PARAMETERS FOLLOWING DORSAL AND VOLAR APPROACH OPEN REDUCTION AND PLATING. BETWEEN 2005 AND 2012, 84 PATIENTS WITH AN INTRA-ARTICULAR COMMINUTED DRF (AO C3 TYPE) UNDERWENT SURGICAL FIXATION WITH EITHER DORSAL OR VOLAR-LOCKING PLATE, AND WERE FOLLOWED MORE THAN 3 MONTHS POSTOPERATIVELY WERE ENROLLED INTO THIS STUDY. THE DLP GROUP CONSISTED OF 28 PATIENTS AND THE VLP GROUP CONSISTED OF 56 PATIENTS. 54 PATIENTS WERE FEMALES AND 30 PATIENTS WERE MALES. THE AVERAGE AGE WAS 59 ± 12 YEARS. THE IMPLANTS USED IN THE DORSAL LOCKING PLATE (DLP) GROUP WERE PAIRED 2.4-MM TITANIUM DORSAL LOCKING PLATES (SYNTHES LTD., PAOLI, PA, USA), ONE PLACED ON THE INTERMEDIATE COLUMN AT THE DORSAL CORTEX AND THE OTHER ON THE RADIAL COLUMN. THE IMPLANT USED IN VOLAR-LOCKING PLATE (VLP) GROUP WAS A SINGLE 2.4-MM TITANIUM VOLAR-LOCKING PLATE (SYNTHES LTD., PAOLI, PA, USA). THE MINIMUM FOLLOW-UP WAS 4 YEARS WITH A MEAN FOLLOW-UP GREATER THAN 6 YEARS (76.6 ± 23.8 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: DLP GROUP. 2 PATIENTS HAD DELAYED WOUND HEALING WITHOUT BEING TREATED WITH ANTIBIOTICS. 6 PATIENTS HAD REOPERATIONS. 2 PATIENTS HAD COMPLEX REGIONAL PAIN SYNDROME. 3 PATIENTS HAD OTHER COMPLAINTS. VLP GROUP. 2 PATIENTS HAD DELAYED WOUND HEALING WITHOUT BEING TREATED WITH ANTIBIOTICS. 9 PATIENTS HAD REOPERATIONS. 1 PATIENTS HAD COMPLEX REGIONAL PAIN SYNDROME. 6 PATIENTS HAD OTHER COMPLAINTS. 1 PATIENT UNDERWENT RECONSTRUCTION OF THE FLEXOR DIGITORUM POLICIES LONGUS TENDON AND OF THE FLEXOR DIGITORUM PROFUNDUS TENDON OF DIGIT II IN ADDITION TO PLATE REMOVAL. 1 PATIENT HAD AND IMPLANT REMOVAL DUE TO IMPLANT IRRITATION ALTHOUGH IT DIDN'T SPECIFY WHICH GROUP THIS PATIENT BELONGED TO. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES PAIRED 2.4-MM TITANIUM DORSAL LOCKING PLATES AND A SINGLE 2.4-MM TITANIUM VOLAR-LOCKING PLATE. (UNKNOWN PLATE/SCREW CONSTRUCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809228 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention