BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19783807 · Received July 19, 2024

    Report

    Report Number
    2210968-2024-07404
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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? 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: WORLD NEUROSURG. (2024) 184:E821-E829. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.02.070.

    Description of Event or Problem · 0

    TITLE: SINGLE SURGEON COMPARISON OF MIDLINE VERSUS OVERLAPPING LOCOREGIONAL FLAP CLOSURE FOLLOWING SPINAL INSTRUMENTATION. THE STUDY SOUGHT TO COMPARE THE POSTOPERATIVE OUTCOMES BETWEEN PATIENTS WHO UNDERWENT COMPLEX BACK CLOSURE USING OVERLAPPING MUSCLE FLAPS AND THOSE WHO UNDERWENT CLOSURE USING FLAPS APPROXIMATED AT THE MIDLINE. BETWEEN JANUARY 2016 AND JULY 2021, A TOTAL OF 110 PATIENTS (48 MALE AND 62 FEMALE) WITH A MEAN AGE OF 51 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS UNDERWENT SPINE SURGERY FOLLOWED BY LOCOREGIONAL MUSCLE FLAP CLOSURE PERFORMED BY A SINGLE PLASTIC SURGEON. PATIENTS WERE DIVIDED INTO MIDLINE AND OVERLAPPING GROUPS BASED ON THE CLOSURE METHOD THAT WAS EMPLOYED. THE MIDLINE GROUP (WITH 47 PATIENTS) USES A 15 FRENCH BLAKE DRAIN (ETHICON) FREQUENTLY PLACED WITHIN THE DEEP SUBMUSCULAR SPACE PRIOR TO CLOSURE. THE FLAPS WERE THEN APPROXIMATED WITH 0 PDS (ETHICON), THE SUPERFICIAL LAYER OF THE MUSCLE ALONG WITH ITS OVERLYING FASCIA WAS RECONSTRUCTED WITH A 1 STRATAFIX KNOTLESS TISSUE CONTROL DEVICES (ETHICON), THE SCARPA¿S FASCIA IS THEN RELEASED ON EITHER SIDE OF THE WOUND USING A 0 STRATAFIX, THE DEEP DERMIS IS CLOSED WITH A 3-0 SPIRAL STRATAFIX, AND A 3-0 MONOCRYL RUNNING SUTURE IS USED TO APPROXIMATE THE TISSUE IN A SUBCUTICULAR FASHION. THE OVERLAPPING ¿VEST-OVER-PANTS¿ GROUP (WITH 63 PATIENTS) USES 0 PDS (ETHICON) TO SECURE THE ERECTOR SPINAE MUSCULATURE ON THE OTHER SIDE FOLLOWING A BILATERAL MUSCLE FLAP RELEASE, WHILE THE SECOND MUSCLE IS BEING LAID ON TOP OF THE FIRST AND SUTURED DOWN WITH 0 PDS OR RUNNING 0 STRATAFIX SUTURES. A 15 FRENCH BLAKE DRAIN (ETHICON) WAS PLACED WITHIN THE DEEP SUBMUSCULAR SPACE PRIOR TO CLOSURE, THE SCARPA¿S FASCIA IS THEN RELEASED ON EITHER SIDE OF THE WOUND USING A 0 STRATAFIX, THE DEEP DERMIS IS CLOSED WITH A 3-0 SPIRAL STRATAFIX, AND A 3-0 MONOCRYL RUNNING SUTURE IS USED TO APPROXIMATE THE TISSUE IN A SUBCUTICULAR FASHION. FOR BOTH GROUP, THE WOUNDS ARE ROUTINELY DRESSED WITH DERMABOND SURGICAL GLUE (ETHICON), ADHESIVE STRIPS (STERI-STRIPS, 3M), AND HYPAFIX TAPE (BSN MEDICAL). REPORTED COMPLICATIONS INCLUDE: (N=33) POSTOPERATIVE RADIATION, (N=13) SURGICAL SITE INFECTION, (N=3) SKIN NECROSIS, (N=6) DEHISCENCE, (N=6) HEMATOMA, (N=20) SEROMA, (N=10) DELAYED WOUND HEALING, (N=15) NEEDS REOPERATION. CONCLUSIONS: THE PRESENT STUDY DEMONSTRATES THAT BOTH THE OVERLAPPING AND MIDLINE APPROXIMATION OF MUSCLE FLAPS ARE EQUALLY SAFE AND EFFECTIVE STRATEGIES FOR LOCOREGIONAL CLOSURE OF SPINAL WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673155 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention