BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22179701 · Received June 10, 2025

    Report

    Report Number
    2210968-2025-06582
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    December 10, 2024
    Report Date
    June 10, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? 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? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: NEUROSURG REV. 2024 DEC 10;47(1):898. DOI: 10.1007/S10143-024-03128-Y. PMID: 39656311; PMCID: PMC11632004. HTTPS://DOI.ORG/10.1007/S10143-024-03128-Y.

    Description of Event or Problem · 0

    SURGICAL OUTCOME AFTER AUTOLOGOUS BONE CHIPS REPLACEMENT IN DEPRESSED SKULL FRACTURES: A SINGLE CENTER EXPERIENCE. THE AIM OF THIS STUDY IS TO EVALUATE DIFFERENT PATTERNS OF OUTCOME INCLUDING (SAFETY, EFFICACY, COMPLICATIONS, PATIENTS¿ SATISFACTION AND NEED FOR LATE CP) OF USING AUTOLOGOUS BONE CHIPS FOR MANAGEMENT OF DEPRESSED SKULL FRACTURES (DSFS). BETWEEN MARCH 2023 AND NOVEMBER 2023, A TOTAL OF 68 TRAUMATIC BRAIN INJURY (TBI) PATIENTS WITH DSFS WERE OPERATED UPON IN OUR NEUROSURGERY DEPARTMENT. BASED ON OUR ELIGIBILITY CRITERIA, 59 PATIENTS FULFILLED OUR INCLUSION CRITERIA AND WERE ACTIVELY INCLUDED. AMONG OUR INCLUDED CASES, (89.8%) HAD MILD TBI AND THE REMAINING (10.2%) HAD MODERATE TBI. THE MEAN AGE WAS (16.505±12.42) YEARS WITH RANGE FROM 6 MONTHS TO 59 YEARS. THE VAST MAJORITY OF PATIENTS 41 CASES (69.5%) WERE =20 YEARS AND 18 PATIENTS (30.5%) WERE >20 YEARS. MALES CONSTITUTED THE MAIN BULK OF STUDY POPULATION (78%) AND FEMALE REPRESENTED ONLY (22%). RTA WAS THE MOST FREQUENT MOOD OF TRAUMA (35.6%) FOLLOWED BY ASSAULT (23.7%), DIRECT TRAUMA (23.47%) THEN FFH (16.9%). VICRYL 0 (ETHICON) WAS USED TO MAKE A NET THROUGH EDGES OF THE GALEA THEN BONE FRAGMENTS WERE REPLACED AND FIXED USING THIS NET. REPORTED COMPLICATIONS ARE : VICRYL 0 (ETHICON), SEIZURES (N=3.4%). TREATMENT : NOT REPORTED CSF LEAKAGE (N=3.4%). TREATMENT : NOT REPORTED WOUND INFECTION (N=1). TREATMENT : WE STARTED EMPIRIC BROAD-SPECTRUM ANTIBIOTIC REGIMEN WITH VANCOMYCIN (15 MG/KG IV EVERY 12 H) PLUS A THIRD A GENERATION CEPHALOSPORIN (CEFTRIAXONE 2 G IV DAILY) AND SHOWED GOOD RESPONSE TO THE ANTIBIOTIC TREATMENT VICRYL 0 (ETHICON) DEATH (N=1); THIS PATIENT HAD WOUND INFECTION AND DEVELOPED OSTEOMYELITIS TREATMENT: THE PATIENT HAD WOUND INFECTION WHICH WAS TREATED WITH EMPIRIC BROAD-SPECTRUM ANTIBIOTIC REGIMEN WITH VANCOMYCIN (15 MG/KG IV EVERY 12 H) PLUS A THIRD A GENERATION CEPHALOSPORIN (CEFTRIAXONE 2 G IV DAILY); DEVELOPED OSTEOMYELITIS AND UNDERWENT RE-SURGERY FOR WOUND DEBRIDEMENT AND REMOVAL OF BONE FRAGMENTS, LATER THIS CASE WAS EXPIRED. IN CONCLUSION, USING AUTOLOGOUS DEPRESSED BONE CHIPS FOR SKULL DEFECT RECONSTRUCTION CAN BE A SAFE AND FEASIBLE SURGICAL TECHNIQUE FOR TBI PATIENTS SUFFERING DSFS WITH GOOD AESTHETIC RESULTS, HIGH PATIENT SATISFACTION, DECREASED NEED FOR LATER CRANIOPLASTY AND CONSEQUENTLY LOW OVERALL MANAGEMENT COST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780452 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention