BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: TRAUMA

    MDR report key: 10609583 · Received September 30, 2020

    Report

    Report Number
    8030965-2020-07569
    Event Type
    Injury
    Date Received
    September 30, 2020
    Report Date
    September 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PATIENT INVOLVED. IMPLANTATION DATE UNKNOWN. THIS REPORT IS FOR AN UNK: PLATES: 3.5 MM LCP MEDIAL DISTAL TIBIA PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ABBOUD A, ET AL. (2020), UNION FOLLOWING BIOLOGICAL AND RIGID FIXATIONS OF DISTAL TIBIA EXTRA-ARTICULAR FRACTURES, THE ARCHIVES OF BONE AND JOINT SURGERY, VOLUME 8, NUMBER 2, PAGE 162-167, (LEBANON). THE PRESENT STUDY AIMED TO ASSESS THE RATE OF DELAYED UNION AND NONUNION OF EXTRA-ARTICULAR DISTAL TIBIA FRACTURES WITH THE USE OF BRIDGE PLATING AND COMPRESSION PLATING. DURING JANUARY 2001 AND 2017, 41 PATIENTS WHO UNDERWENT THE SURGICAL FIXATION OF DISTAL TIBIA FRACTURES USING COMPRESSION PLATING OR BRIDGE PLATING WERE INCLUDED IN THE STUDY. THE BRIDGE PLATING GROUP CONSISTED OF 25 PATIENTS WITH 16 MALES AND 9 FEMALES WITH A MEAN AGE OF 44.96 +/-16.21 YEARS. MEANWHILE, THE COMPRESSION PLATING GROUP CONSISTED OF 16 PATIENTS WITH 5 MALES AND 10 FEMALES WITH A MEAN AGE OF 46.93 +/- 13.69 YEARS. FOR BOTH FIXATION METHODS, AN UNKNOWN SYNTHES 3.5 MM LOCKING COMPRESSION PLATE MEDIAL DISTAL TIBIAL PLATES WERE USED IN THIS STUDY. THE LENGTH OF THE USED PLATES WAS EITHER 194 (10-HOLE PLATE) OR 220 MM (12-HOLE PLATE). DISTALLY, 5 OR 6 UNICORTICAL SCREWS (OBTAINING 5-6 CORTICES) WERE INSERTED IN A LOCKING FASHION; HOWEVER, 3 OR 4 BICORTICAL SCREWS (OBTAINING 6-8 CORTICES) WERE ALSO PROXIMALLY INSERTED IN A LOCKING FASHION. COMPLICATIONS WERE REPORTED AS FOLLOWS: (BRIDGE PLATE GROUP) 9 PATIENTS HAD DELAYED UNION. 2 PATIENTS HAD NON-UNION. 2 PATIENTS DID NOT HEAL AND WERE MANAGED WITH REOPERATION FOR HYPERTROPHIC NONUNION WITH BONE GRAFT PLACEMENT. (COMPRESSION GROUP) 2 PATIENTS HAD DELAYED UNION. 1 PATIENT HAD NON-UNION. 1 PATIENT DID NOT HEAL AND WAS MANAGED WITH REOPERATION FOR HYPERTROPHIC NONUNION WITH BONE GRAFT PLACEMENT. THIS REPORT IS FOR THE UNKNOWN SYNTHES 3.5 MM LOCKING COMPRESSION PLATE MEDIAL DISTAL TIBIAL PLATES AND UNKNOWN SYNTHES SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074836 UNK - SCREWS: TRAUMA SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention