BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18713424 · Received February 15, 2024

    Report

    Report Number
    2210968-2024-01418
    Event Type
    Injury
    Date Received
    February 15, 2024
    Date of Event
    November 30, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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? 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 RELATED EVENTS CAPTURED VIA 2210968-2024-01419. CITATION: SURGICAL NEUROLOGY INTERNATIONAL.2021; VOL. 12 ( 587 ): 1 - 7.10 25259/SNL_861_2021 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE : THREE DIMENSIONAL CUSTOM-MADE PEEK CRANIOPLASTY. THE AIM OF THIS PROSPECTIVE RANDOMIZED COMPARATIVE STUDY WAS TO COMPARE THE ESTHETIC AND FUNCTIONAL OUTCOME OF CUSTOM-MADE THREE-DIMENSIONAL (3D) CRANIOPROSTHESES TO HANDMADE BONE CEMENT IN RECONSTRUCTING CALVARIAL SKULL DEFECTS. BETWEEN (B)(6) 2017 AND (B)(6) 2020, A TOTAL OF 66 PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS: 33 IN GROUP 1 WHO HAD CUSTOM-MADE 3D CRANIOPROSTHESES; 33 IN GROUP 2 WHO HAD HANDMADE IMPLANTS. IN GROUP 1, 24 PATIENTS WERE MALES WHILE 9 WERE FEMALES WITH A MEAN AGE OF 25.7 (12.9). HOWEVER, IN GROUP 2, 13 PATIENTS WERE MALES WHILE 20 WERE FEMALES WITH A MEAN AGE OF 26.8 (14.8). THE IMPLANT OF GROUP 1 WAS FIXED USING SILK OR PROLENE SUTURES WHILE IN GROUP 2, A PIECE OF PROLENE MESH WAS PLACED OVER THE DURA BEFORE PLACING THE IMPLANT. THE REPORTED COMPLICATIONS INCLUDED THE FOLLOWING: IN GROUP 1: EARLY COMPLICATIONS OF SUB-GALEAL COLLECTION (N=3) AND EPIDURAL COLLECTIONS (N=1). IN GROUP 2: EARLY COMPLICATIONS OF SUB-GALEAL COLLECTION (N=4) AND EPIDURAL COLLECTION (N=1), AND POST-OPERATIVE INFECTION (N=1); LATE COMPLICATIONS OF SUBGALEAL COLLECTION AND INFECTION WITH NO NEED FOR FLAP REMOVAL (N=1), INFECTION AND NEEDED FLAP REMOVAL (N=1), INFECTION THAT LED TO HYDROCEPHALUS (N=1), AND INFECTION WHICH LED TO FLAP EXPOSURE AND UNDERGONE FLAP REMOVAL (N=2). IN CONCLUSION, CRANIOPLASTY USING THREE DIMENSIONAL CUSTOMS MADE PEEK PROSTHESIS IS A RELIABLE METHOD WHICH SAVES OPERATIVE TIME, LOWERS COST AND PROVIDES LESS COMPLICATIONS IF COMPARED WITH OTHER CRANIOPLASTY TECHNIQUES. CUSTOM-MADE 3D CRANIOPROSTHESES ARE BETTER THAN HANDMADE BONE CEMENT IN RECONSTRUCTING CALVARIAL DEFECTS IN TERMS OF ESTHETIC AND FUNCTIONAL OUTCOME AS WELL AS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504099 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other