BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI PDS+ UNI VIO 27IN 3-0 SA PS-2 PR

    MDR report key: 21305214 · Received February 4, 2025

    Report

    Report Number
    2210968-2025-01325
    Event Type
    Injury
    Date Received
    February 4, 2025
    Report Date
    April 16, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031235762
    PMA / PMN Number
    K150670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IS THE EXACT NUMBER OF PATIENTS WITH A POST-OP INFECTION KNOWN? ¿NO IF YES, PLEASE PROVIDE THE TOTAL NUMBER OF PATIENTS.¿N/A IF THE TOTAL NUMBER OF PATIENTS IS MORE THAN 2, PLEASE CREATE 1 ADDITIONAL PC PER PATIENT.¿UNK FOR EACH PATIENT, PLEASE PROVIDE THE FOLLOWING: WE ANSWERED FOR INFORMATION FOR EACH CASE IN THE EACH PC-XXXXXXXXX PAGE. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE¿UNK DATE AND NAME OF INDEX SURGICAL PROCEDURE? => SPINE UNKNOWN SURGERY. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ¿UNK WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)?¿UNK ON WHAT TISSUE WAS THE SUTURE USED?¿SUBCUTANEOUS DERMIS WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)?¿UNK WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE?¿UNK WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE?¿UNK PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION).¿UNK PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE.¿UNK WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE?¿UNK DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION?¿UNK WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS.¿UNK HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND?¿UNK PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS.¿UNK WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE.¿UNK DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION?¿UNK OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS?¿UNK WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT?¿UNK WHAT IS THE PATIENT'S CURRENT STATUS? =>UNK LOT NUMBER? =>UNK THE DOCTOR WOULD NOT TO PROVIDE US WITH MORE INFORMATION. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED IN ECM NOTE."

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS ARE BEING MADE TO INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. IS THE EXACT NUMBER OF PATIENTS WITH A POST-OP INFECTION KNOWN? IF YES, PLEASE PROVIDE THE TOTAL NUMBER OF PATIENTS. IF THE TOTAL NUMBER OF PATIENTS IS MORE THAN 2, PLEASE CREATE 1 ADDITIONAL PC PER PATIENT. FOR EACH PATIENT, PLEASE PROVIDE THE FOLLOWING: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY FOR SPINAL DISEASE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USE. POST-OP, SURGICAL SITE INFECTION OCCURRED A FEW DAYS AFTER THE PROCEDURE. IT WAS STATED THE SAME DOCTOR CONTINUED TO USE THE BARBED SUTURE ON THE SUBCUTANEOUS DERMIS FOR SPINAL DISEASE CASES IN GENERAL BEFORE 2020. ACCORDING TO THE DOCTOR, THERE HAVE BEEN SEVERAL CASES OF SURGICAL SITE INFECTION RECENTLY, AND WHETHER THEY WERE CAUSED BY THE BARBED SUTURE OR NOT IS NOT CERTAIN, BUT THE DOCTOR HAS A SUSPICION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310284 SFXSPI PDS+ UNI VIO 27IN 3-0 SA PS-2 PR SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 10705031235762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other