BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7681222 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74275
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: MEDICINE (2017) 96:11(E6099); DOI: HTTP://DX.DOI.ORG/10.1097/MD.0000000000006099. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SURGICAL TREATMENT FOR BACTERIAL MENINGITIS AFTER SPINAL SURGERY. A CASE REPORT". AUTHOR(S): LI-MIN ZHANG, MD, LIANG REN, MD, ZHEN-QI ZHAO, MD, YAN-RUI ZHAO, MD, YIN-FENG ZHENG, MD, JUN-LIN ZHOU, MD, PHD. CITATION: MEDICINE (2017) 96:11(E6099); DOI: HTTP://DX.DOI.ORG/10.1097/MD.0000000000006099. THE STUDY AIMED TO PRESENT A (B)(6) FEMALE PATIENT WHO HAD DAMAGED DURA MATER INTRAOPERATIVELY DURING TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-L5 FOR WHICH IT WAS NOT SUTURED OWING TO THE SIZE OF THE DURAL TEAR (5MM) AND ITS LOCATION. POSTOPERATIVE DAY 16, A BULGING MASS WITH A BALLOTABLE COLLECTION OF FLUID WAS DETECTED UNDER THE WOUND, AND 60ML OF TURBID CSF WERE WITHDRAWN THROUGH A WOUND PUNCTURE. THE PATIENT UNDERWENT SECOND OPERATION TO REPAIR THE TORN DURA MATER WHICH WAS NOTED ON THE L5 THECAL SAC. THE DURAL DEFECT WAS SUTURED WITH A 5-0 PROLENE SUTURE AND A MUSCLE PLUG. THREE DAYS AFTER THE SECOND SURGERY, SHE WAS DIAGNOSED WITH CUTANEOUS CSF FISTULA WITH SYMPTOMS OF PYREXIA AND SEVERE HEADACHES AND WAS TREATED WITH VANCOMYCIN 1 G TWICE DAILY. HOWEVER, 10 DAYS AFTER, THE PATIENT PRESENTED DIZZINESS AND VOMITING AND CSF CULTURE REVEALED PSEUDOMONAS AERUGINOSA, WHICH WAS SENSITIVE TO VANCOMYCIN, MEROPENEM, PIPERACILLIN, AND TAZOBACTAM. THE PATIENT WAS THEN DIAGNOSED WITH POSTOPERATIVE BACTERIAL MENINGITIS. THE PATIENT WAS TREATED WITH PIPERACILLIN AND TAZOBACTAM (4.5G TWICE DAILY FOR 8 DAYS) FOR EPISODE OF PAERUGINOSA INFECTION. THE PATIENT ALSO TREATED WITH REPEATED DEBRIDEMENT AND THE LACERATION OF THE DURA MATER WAS REPAIRED WITH FASCIAL GRAFT AND FIBRIN GLUE. FURTHER, AN EPIDURAL DRAIN WAS PLACED, AND THE PARASPINAL MUSCLES AND FASCIA WERE CLOSED IN 2 LAYERS, IN A FIGURE-OF-EIGHT FASHION, TO CREATE A WATERTIGHT CLOSURE. TREATMENT WITH VANCOMYCIN (0.5G TWICE DAILY FOR 17 DAYS) AND MEROPENEM (0.5G TWICE DAILY FOR 20 DAYS) WAS STARTED AFTER THE THIRD OPERATION. THE PATIENT IMPROVED RAPIDLY AND WAS DISCHARGED. NINE DAYS AFTER DISCHARGE, THE PATIENT HAD REAPPEARANCE OF SEVERE HEADACHE AND ALTERED MENTAL STATUS WITH PURULENT CSF FROM A LUMBAR PUNCTURE. CULTURE REVEALED ESCHERICHIA COLI INFECTION FOR WHICH MEROPENEM 500MG WAS ADMINISTERED INTRAVENOUSLY TWICE A DAY FOR 14 DAYS. THE PATIENT DID NOT HAVE FEVER THEREAFTER AND THE INFECTION HEALED. BACTERIAL MENINGITIS IS A COMPLICATION OF SPINAL SURGERY, USUALLY RESULTING FROM DIRECT BACTERIAL INVASION OF THE MENINGES THROUGH A DURAL RUPTURE WITH CSF LEAKAGE. IN THIS CASE, INAPPROPRIATE ANTIBIOTIC ADMINISTRATION AND IMPERFECT SUTURE OF THE DURA OR FASCIA DURING TREATMENT MAY HAVE CONTRIBUTED TO THE INITIAL DEVELOPMENT OF MENINGITIS, AND THE MENINGITIS RELAPSE MAY HAVE OCCURRED OWING TO THE SHORT-TERM ANTIBIOTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523232 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention