BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12586799 · Received October 6, 2021

    Report

    Report Number
    2210968-2021-09300
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    February 3, 2020
    Report Date
    October 6, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #(B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: 2020 AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS 0278-2391/20/30116-6. HTTPS://DOI.ORG/10.1016/J.JOMS.2020.02.002.

    Description of Event or Problem · 1

    TITLE: PERCUTANEOUS REDUCTION OF ISOLATED ZYGOMATIC ARCH FRACTURES: A 5-YEAR EXPERIENCE THE AIM OF THIS STUDY IS REPORT OUR EXPERIENCE USING A MINIMALLY INVASIVE TECHNIQUE, PREVIOUSLY DESCRIBED IN 2013, TO TREAT ISOLATED ZA FRACTURES. A TOTAL OF 15 PATIENTS (11 MEN, 4 WOMEN) WITH MEAN AGE OF 39.0 YEARS (RANGE, 19 TO 75 YEARS) WERE INCLUDED. USING THE CLASSIFICATION REPORTED BY KIM ET AL, 9 PATIENTS PRESENTED WITH A TYPE 1A FRACTURE, 6 WITH A TYPE 1B FRACTURE, AND NONE WITH A TYPE 1C FRACTURE. NONE OF THE PATIENTS PRESENTED WITH PREOPERATIVE FUNCTIONAL LIMITATION OF MOUTH OPENING, HEMATOMA, OPEN FRACTURE, FACIAL PARESIS, OR PARALYSIS. HOWEVER, ALL THE PATIENTS PRESENTED WITH CLINICALLY APPRECIABLE FACIAL ASYMMETRY. THE TECHNIQUE WAS PERFORMED USING THE SAME SUTURE WIRE (VICRYL 1 WITH CTX 48-MM, ½ ROUND BONDED NEEDLE; ETHICON, SOMERVILLE, NJ) AND THE SAME EXTERNAL FIXATION SPLINT (ZIMMER SPLINT HAND MOLDED; ZIMMER BIOMET, WARSAW, IN) FOR EVERY PATIENT. EXTERNAL FIXATION WAS ACHIEVED USING AN ADEQUATE LENGTH TO DISPLACE THE PRESSURE FORCES ON NONFRACTURED BONY STRUCTURES AFTER EVALUATION OF THE PREOPERATIVE CT SCANS. THE MALAR BUTTRESS AND THE ZA WERE MARKED WITH A SKIN MARKING PEN. THE FRACTURE SITE WAS IDENTIFIED BY PALPATING THE MALAR SKIN AND MARKING IT. TWO VICRYL 1 SUTURE WIRES WITH A CTX 48-MM ½ ROUND BONDED NEEDLE (ETHICON) WERE PASSED THROUGH THE SKIN JUST BELOW THE ZA, BEHIND IT, AND BROUGHT OUT JUST ABOVE IT. THE FRACTURE WAS REDUCED BY PULLING THE WIRES. THE APPROPRIATE POSITION OF THE FRAGMENTS WAS CHECKED BY ASSESSING THE FACIAL SYMMETRY AND THE ABSENCE OF BONY STEPS BY PALPATING THE MALAR SKIN. FINALLY, AN EXTERNAL ZIMMER SPLINT (ZIMMER BIOMET) WAS FIXED BY TIGHTENING AND LATCHING THE WIRES OVER IT. IN 13 PATIENTS, WE OBTAINED SATISFACTORY ALIGNMENT OF THE FRACTURE FRAGMENTS, WHICH WAS DETERMINED BY IMMEDIATE PALPATION AND CONFIRMED BY THE POSTOPERATIVE RADIOGRAPH OR CT SCAN FINDINGS. IN 2 PATIENTS, THE PROCEDURE DID NOT RESULT IN GOOD REDUCTION OF THE FRACTURE FRAGMENTS. THE FIRST OF THESE PATIENTS DEVELOPED AN EARLY HEMATOMA AND THE SECOND PRESENTED WITH A MINIMAL ALIGNMENT DEFECT SEEN ON THE POSTOPERATIVE CR FOLLOW-UP IMAGING STUDY THAT WAS CLINICALLY UNAPPRECIABLE. A GILLES APPROACH WAS USED TO OBTAIN ALIGNMENT. THUS, USE OF THE WIRES COULD NOT PRODUCE AN ADEQUATE LIFTING FORCE TO COMPLETE THE REDUCTION. NO PATIENT REQUIRED FURTHER TREATMENT. AN AVERAGE OF 15.8 DAYS AFTER SURGERY (14.1 DAYS FOR TYPE 1A FRACTURES AND 18.5 DAYS FOR TYPE 1B FRACTURES; TABLE 1). NO PATIENT PRESENTED WITH AN EARLY COMPLICATION, INCLUDING WOUND INFECTION, BLEEDING, OR DROP OF THE FRACTURED FRAGMENTS. DURING THE 6-MONTH FOLLOW-UP PERIOD, NONE OF THE PATIENTS PRESENTED WITH LONG-TERM COMPLICATIONS, SUCH AS FACIAL ASYMMETRY, SCARS, MALAR DEPRESSION, OR FUNCTIONAL DEFICITS IN MOUTH OPENING. ALL THE PATIENTS HAD UNDERGONE SUBMENTAL VERTEX (BUCKETHANDLE) PLAIN RADIOGRAPHS TO CONFIRM PROPER FRACTURE REDUCTION. THE SPLINT AND SUTURES WERE REMOVED AFTER 2 WEEKS. ALL SURGICALLY AND NONSURGICALLY TREATED PATIENTS WERE ADVISED TO NOT APPLY PRESSURE ON THE FRACTURED SIDE FOR A PERIOD OF 6 WEEKS. REPORTED POSTOPERATIVE COMPLICATION INCLUDED N=1 HEMATOMA AND N=1 MINIMAL ALIGNMENT DEFECT. IN CONCLUSION, THE RESULTS OF THE PRESENT STUDY SUGGEST THAT OPTIMAL ESTHETIC AND FUNCTIONAL RESULTS CAN BE OBTAINED, MINIMIZING THE EFFECT ON SOFT TISSUES AND PATIENT DISCOMFORT, WITH A SHORT SURGICAL TIME AND LOW RATE OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483868 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention