BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 8148091 · Received December 10, 2018

    Report

    Report Number
    8030965-2018-58886
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    December 30, 2017
    Report Date
    November 19, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN 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. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OFFODILE II, AC ET AL (2018). ANTEROLATERAL THIGH FLAP COMBINED WITH RECONSTRUCTION PLATE VERSUS DOUBLE FREE FLAPS FOR COMPOSITE MANDIBULAR RECONSTRUCTION: A PROPENSITY SCORE-MATCHED STUDY. ANNALS OF SURGICAL ONCOLOGY. VOLUME 25. PAGES 829-836. (TAIWAN). THIS RETROSPECTIVE STUDY AIMS TO EXAMINE THE COMPARATIVE EFFECTIVENESS OF OROMANDIBULAR DEFECT RECONSTRUCTION VIA ANTEROLATERAL THIGH FLAP AND BRIDGING PLATE (ALT ONLY) VERSUS SIMULTANEOUS SOFT TISSUE AND VASCULARIZED BONE FLAP (DFF), WITH REGARDS TO LONG-TERM PLATE EXPOSURE AND COMPLICATIONS. BETWEEN JANUARY 2008 AND JUNE 2013, 160 PATIENTS UNDERWENT MICROVASCULAR RECONSTRUCTION OF A COMPOSITE OROMANDIBULAR DEFECT FOLLOWING ONCOLOGIC EXTIRPATION. 62 PATIENTS WERE 1:1 PROPENSITY-MATCHED AND WERE INCLUDED IN THE STUDY. 2 SURGICAL GROUPS WERE CREATED, THE ALT ONLY GROUP (31 PATIENTS WITH 29 MALES, AN AVERAGE AGE OF 54.3+/-10.3 YEARS) AND THE DFF GROUP (31 PATIENTS WITH 30 MALES, AN AVERAGE AGE OF 52.0+/-12.4 YEARS). THE UNKNOWN SYNTHES LOCKING MANDIBULAR RECONSTRUCTION PLATE FIXATION SYSTEM WAS USED TO SPAN THE MANDIBULAR DEFECT OR SECURE THE FREE FLAP (FF) IN ALL CASES. POST-OPERATIVE ASSESSMENT INCLUDED PAIN, APPEARANCE, EMPLOYMENT, SPEECH, AND SWALLOWING. SCORING IS BASED ON A SCALE OF 0 (WORST) TO 100 (BEST), AND ALL PATIENTS RECEIVED THE QUESTIONNAIRE AT LEAST 12 MONTHS AFTER SURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: (ALT ONLY GROUP) 1 PATIENT HAD A MEDICAL COMPLICATION. 12 PATIENTS HAD WOUND INFECTION OR FISTULA. 5 PATIENTS UNDERWENT DEBRIDEMENT. 12 PATIENTS HAD PLATE EXPOSURE. 3 PATIENTS WERE TREATED CONSERVATIVELY. 8 PATIENTS HAD ONLY THE PLATES REMOVED. 1 PATIENT HAD THE PLATE AND 2ND FLAP (VASCULARIZED FIBULA FLAP) REMOVED. 21 PATIENTS HAD A SOFT OR LIQUID DIET. 6 PATIENTS HAD A PARTIAL TUBE FEEDING. 4 PATIENTS HAD A TOTAL TUBE FEEDING. PAIN MEAN SCORE OF 75.2 ± 10.1 PER QOL EVALUATION. SWALLOWING MEAN SCORE OF 75.3 ± 22.1 PER QOL EVALUATION. SPEECH MEAN SCORE OF 72.1 ± 23.5 PER QOL EVALUATION. APPEARANCE MEAN SCORE OF 55.3 ± 19.9 PER QOL EVALUATION. EMPLOYMENT MEAN SCORE OF 42.3 ± 27.1 PER QOL EVALUATION. 1 PATIENT HAD PLATE FRACTURE. (DFF GROUP) 5 PATIENTS HAD A MEDICAL COMPLICATION. 4 PATIENTS HAD WOUND INFECTION OR FISTULA. 7 PATIENTS UNDERWENT DEBRIDEMENT. 11 PATIENTS HAD PLATE EXPOSURE. 10 PATIENTS HAD ONLY THE PLATES REMOVED. 1 PATIENT HAD THE PLATE AND 2ND FLAP (ALT FLAP)REMOVED. 22 PATIENTS HAD A SOFT OR LIQUID DIET. 6 PATIENTS HAD A PARTIAL TUBE FEEDING. 3 PATIENTS HAD A TOTAL TUBE FEEDING. PAIN MEAN SCORE OF 88.5 ± 10.3PER QOL EVALUATION. SWALLOWING MEAN SCORE OF 81.2 ± 28.9 PER QOL EVALUATION. SPEECH MEAN SCORE OF 80.3 ± 35.2 PER QOL EVALUATION. APPEARANCE MEAN SCORE OF 62.1 ± 23.2 PER QOL EVALUATION. EMPLOYMENT MEAN SCORE OF 43.2 ± 28.5 PER QOL EVALUATION. THIS REPORT IS FOR ONE (1) UNKNOWN SYNTHES LOCKING MANDIBULAR RECONSTRUCTION PLATE FIXATION SYSTEM. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985247 PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention