BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFX SYM PDS+ VIO 18IN 1 S/A CT-1

    MDR report key: 8166258 · Received December 14, 2018

    Report

    Report Number
    2210968-2018-77776
    Event Type
    Injury
    Date Received
    December 14, 2018
    Report Date
    November 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031227699
    PMA / PMN Number
    K113004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 01/16/2019. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PRIMARY DIAGNOSIS: L4 # L3/4/5 STENOSIS. PRIMARY PROCEDURE: LEFT L3/4/5 DECOMPRESSION; L2-L5 FIXATION; L3-L5 POSTEROLATERAL FUSION. IMPLANTS: EVEREST SCREWS (LHC), CEMENT. WOUND CLOSURE: 1 STRATAFIX/2.0 STRATFIX/PRINEO; 5.0 PROLENE FOR DURAL HOLE. (B)(6) 2018: ROUTINE POST-OP CT. REVISION: HOSPITAL/DATE: (B)(6) 2018 (CURRENT INPATIENT). PRIMARY DIAGNOSIS: WOUND BREAKDOWN/INFECTION PROCEDURE 2: DEBRIDE & RE-SUTURE LUMBAR WOUNDS X2. WOUND CLOSURE:1 VICRYL/1 VICRYL/2.0 VICRYL/3.0 NYLON/ TENSION SUTURES. ANTIMICROBIAL THERAPY: IV TAZOCIN 4.5G THREE TIME A DAY. WHAT WAS THE DATE OF THE SECOND PROCEDURE? (B)(6) 202018. WHAT TISSUE LAYER WAS THE SYMMETRIC SUTURE USED? NOT PROVIDED. WERE 2 SYMMETRIC SUTURE USED (ONE ON EACH SIDE)? NOT PROVIDED. WERE ANY CULTURES TAKEN OF THE WOUND? WHAT WERE THE RESULTS OF THE CULTURES? (B)(6) 2018: MICROBIOLOGY FROM WOUND SWAB INDICATES LIGHT GROWTH OF ESCHERICHIA COLI & MIXED ANAEROBES & STAPH AUREUS & GRANULICATELLA ADIACENS. WHAT IS THE SURGEON OPINION AS TO RELATIONSHIP OF THE STRATAFIX SYMMETRIC SUTURE AND THE PATIENT INFECTION? SURGEON ADVISED THAT THERE WERE A FEW FACTORS THAT HAS CONTRIBUTED. PRINEO BEING REMOVED TOO EARLY BY STAFF OR MOISTURE AND ROLLED OFF (RE-TRAINED). INSUFFICIENT CLOSURE LEAVING DEAD SPACE (RE-TRAINED ASSISTANT) SINCE ADDRESSING THESE ISSUES, SURGEON'S PATIENTS ALL HEALING WELL. CAN YOU PROVIDE PATIENT AGE, GENDER, WEIGHT, OTHER MEDICAL CONDITIONS? CO-MORBIDITIES. TYPE 2 DIABETES, HYPERTENSION, HX CANCER. WHAT IS THE CURRENT CONDITION OF THE PATIENT? FOLLOW-UP APPOINTMENTS: TBA: PRACTICE NURSE. (B)(6) 2019: SURGEON.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 02/26/2019. PROCEDURE 1 (TRANSFER FROM (B)(6) HOSPITAL). HOSPITAL/DATE: (B)(6) 2018. PRIMARY DIAGNOSIS:L4 # L3/4/5 STENOSIS. PROCEDURE 1: LEFT L3/4/5 DECOMPRESSION; L2-L5 FIXATION; L3-L5 POSTEROLATERAL FUSION. IMPLANTS: EVEREST SCREWS (LHC), CEMENT. WOUND CLOSURE: 1 STRATAFIX/2.0 STRATAFIX/PRINEO; 5.0 PROLENE FOR DURAL HOLE. PATIENT NOTES: (B)(6) 2018: ROUTINE POST-OP CT. PROCEDURE 2: HOSPITAL/DATE: (B)(6) 2018 (CURRENT INPATIENT). PRIMARY DIAGNOSIS: WOUND BREAKDOWN/INFECTION. PROCEDURE 2: DEBRIDE & RE-SUTURE LUMBAR WOUNDS X2. WOUND CLOSURE: 1 VICRYL/1 VICRYL/2.0 VICRYL/3.0 NYLON/ TENSION SUTURES. ANTIMICROBIAL THERAPY: IV TAZOCIN 4.5G TDS. PATIENT NOTES: (B)(6) 2018: MICROBIOLOGY FROM WOUND SWAB INDICATES LIGHT GROWTH OF ESCHERICHIA COLI & MIXED ANAEROBES & STAPH AUREUS & GRANULICATELLA ADIACENS. FOLLOW-UP APPOINTMENTS: TBA: PRACTICE NURSE. (B)(6) 2019: DR (B)(6). CO-MORBIDITIES: TYPE 2 DIABETES, HYPERTENSION, HX CANCER.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. 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. WHAT WAS THE DATE OF THE SECOND PROCEDURE? WHAT TISSUE LAYER WAS THE SYMMETRIC SUTURE USED? WERE 2 SYMMETRIC SUTURE USED (ONE ON EACH SIDE)? WERE ANY CULTURES TAKEN OF THE WOUND? WHAT WERE THE RESULTS OF THE CULTURES? WHAT IS THE SURGEON OPINION AS TO RELATIONSHIP OF THE STRATAFIX SYMMETRIC SUTURE AND THE PATIENT INFECTION? CAN YOU PROVIDE PATIENT AGE, GENDER, WEIGHT, OTHER MEDICAL CONDITIONS? WHAT IS THE CURRENT CONDITION OF THE PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT L4/5 DECOMPRESSION AND L3-L5 FIXATION WITH FUSION ON (B)(6) 2018 AND BARBED SUTURE WAS USED. THE SUTURE WAS USED ON FASCIA AND MUSCLE. THE PATIENT EXPERIENCED WOUND DEHISCENCE AND INFECTION ON UNKNOWN DATE. THE BILATERAL WOUNDS WERE STILL INTACT. THE MIDLINE AND BONE GRAFT INCISIONS HAD SEVERE DEHISCENCE TO THE FASCIA MUSCLE. A SECOND PROCEDURE WAS PERFORMED ON UNKNOWN DATE. IT WAS REPORTED THAT THE SUTURE LOOKED TO BE INTACT. THE INITIAL INCISION WAS AROUND 5-10 CM AND THE SURGEON EXTENDED THE INCISION TO ABOUT 20 CM TO REMOVE LARGE AREA OF TISSUE, THEN USED A DIFFERENT SUTURE TYPE TO CLOSE THE WOUND. THE SURGEON OPINED THAT THE POSSIBLE OUTCOME WAS DUE TO INSUFFICIENT CLOSURE LEAVING DEAD SPACE. THE PATIENT CURRENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003756 SFX SYM PDS+ VIO 18IN 1 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. 10705031227699

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention