BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7681744 · Received July 12, 2018

    Report

    Report Number
    8030965-2018-54969
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 14, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENTS (12 MALES AND 9 FEMALES) WITH MEAN AGE OF 37.1 YEARS (RANGE, 21-53 YEARS). 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: LIU, H. ET AL (2017), SURGICAL MANAGEMENT OF HAWKINS TYPE III TALAR NECK FRACTURE THROUGH THE APPROACH OF MEDIAL MALLEOLAR OSTEOTOMY AND MINI-PLATE FOR FIXATION, JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, VOL. 12(111), PAGES 1-9 (CHINA). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE THE SURGICAL TREATMENT STRATEGY OF HAWKINS TYPE III TALAR NECK FRACTURES THROUGH APPROACH OF MEDIAL MALLEOLAR OSTEOTOMY AND MINI-PLATE FOR FIXATION AND TO ASSESS THE THERAPEUTIC EFFECTS AFTER LONG-TERM FOLLOW-UP. BETWEEN JANUARY 2010 AND JANUARY 2015, 21 PATIENTS (12 MALES AND 9 FEMALES) WITH MEAN AGE OF 37.1 YEARS (RANGE, 21-53 YEARS) UNDERWENT MEDIAL MALLEOLAR OSTEOTOMY AND MINI-PLATE FIXATION. THE INJURED CHONDRAL SURFACE AND FRACTURE WAS FIXED USING UNKNOWN SYNTHES MINI-SCREWS AND UNKNOWN SYNTHES MINI-PLATE. HAWKINS SCORE CONSISTS OF THREE PARTS: PAIN, THE PRESENCE OF A LIMP, AND RANGE OF MOTION OF THE ANKLE. PAIN WAS ASSIGNED FROM 0 TO 6 POINTS: NO PAIN AS 6 POINTS, PAIN ONLY AFTER FATIGUE AS 3 POINTS, AND PAIN AFTER WALKING AS 0 POINT. THE PRESENCE OF LIMP RANGED FROM 0 TO 3 POINTS: 3 POINTS FOR NO LIMP AND 0 POINT FOR THE PRESENCE OF A LIMP. THE RANGES OF MOTION OF THE ANKLE AND SUBTALAR JOINT WERE RATED FROM 0 TO 3 POINTS, RESPECTIVELY: FULL MOTION AS 3 POINTS, PARTIAL MOTION AS 2 POINTS, AND THE FIXED DEFORMITY AS 0 POINT. OVERALL, ¿EXCELLENT¿ WAS CLASSIFIED AS A CUMULATIVE SCORE OF 13 TO 15, ¿GOOD AS 10 TO 12, ¿FAIR¿ AS 7 TO 9 AND ¿POOR¿ AS 6 OR LESS. THE AMERICAN ORTHOPAEDIC FOOT AND ANKLE SOCIETY (AOFAS) ANKLE-HINDFOOT SCORE WAS ALSO USED TO ASSESS FUNCTIONAL OUTCOME. THE FUNCTIONAL RESULTS WERE OBTAINED REGULARLY POSTOPERATIVELY. FOLLOW-UP WAS CONDUCTED BETWEEN 18 AND 41 MONTHS POST-OPERATION, WITH AN AVERAGE OF 29.6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: MEAN VAS SCORE OF 3.2±1.1 . MEAN HAWKINS SCORE OF 11.4±3.4. AVERAGE AOFAS HIND FOOT SCORE OF 79.8 ± 17.3. AVASCULAR NECROSIS (AVN). COMPLETE AVN OF THE TALAR BONES. PARTIAL AVN OF THE TALAR BONES. SUPERFICIAL INFECTIONS. PARTIAL WOUND DEHISCENCE. MALUNION. TALOCRURAL ARTHRITIS. SUBTALAR ARTHRITIS. TALONAVICULAR ARTHRITIS. MALUNION, SECONDARY SURGERY WHERE A PEDICLED PERIOSTEUM FLAP COVERAGE WAS PERFORMED. ARTHRITIS, SECONDARY SURGERY AND RECEIVED SUBTALAR ARTHRODESIS. ARTHRITIS, SECONDARY SURGERY AND RECEIVED ANKLE ARTHRODESIS. ARTHRITIS, SECONDARY SURGERY AND RECEIVED TOTAL ANKLE REPLACEMENT. FAIR AOFAS ANKLE-HINDFOOT SCORE CUMULATIVE SCORE. POOR AOFAS ANKLE-HIND FOOT SCORE CUMULATIVE SCORE. THIS REPORT IS FOR AN UNKNOWN SYNTHES MINI-SCREWS. THIS IS REPORT 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524622 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention