BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7812671 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00035
    Event Type
    Injury
    Date Received
    August 24, 2018
    Report Date
    July 31, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. NO SERIAL NUMBER WAS IDENTIFIED, AS SUCH A DHR REVIEW COULD NOT BE PERFORMED. THE COMPLAINT REPORTED CANNOT BE CONFIRMED. THE STUDY IS NOT CONCLUSIVE OF RELATING THE REPORTED CONDITIONS WITH DURAGEN PRODUCTS. ROOT CAUSE CANNOT BE NOT DETERMINED AT THIS TIME. DOI: 10.1177/2192568216688186.

    Description of Event or Problem · 1

    GLOBAL SPINE JOURNAL (2017) PUBLISHED "A MULTICENTER STUDY OF THE PRESENTATION, TREATMENT, AND OUTCOMES OF CERVICAL DURAL TEARS" IN WHICH A MULTICENTER STUDY WAS PERFORMED TO BETTER UNDERSTAND THE PRESENTATION, TREATMENT, AND OUTCOMES FOLLOWING CERVICAL DURAL TEARS BECAUSE CERVICAL DURAL TEARS ARE RARE, MOST SURGEONS HAVE LIMITED EXPERIENCE WITH THIS COMPLICATION. MULTIPLE SURGEONS FROM 23 INSTITUTIONS RETROSPECTIVELY IDENTIFIED 21 RARE COMPLICATIONS THAT OCCURRED BETWEEN 2005 AND 2011, INCLUDING UNINTENTIONAL CERVICAL DURAL TEARS. MEDICAL RECORDS FOR 17 625 PATIENTS WHO RECEIVED CERVICAL SPINE SURGERY (LEVELS FROM C2 TO C7) BETWEEN JANUARY 1, 2005, AND DECEMBER 31, 2011, WERE REVIEWED TO IDENTIFY OCCURRENCE OF 21 PREDEFINED TREATMENT COMPLICATIONS INCLUDING DURAL TEAR. THERE WERE 109 CASES OF CERVICAL DURAL TEARS IDENTIFIED. INTRAOPERATIVE TREATMENTS OF THE DURAL TEAR INCLUDED DIRECT SUTURE REPAIR, USE OF SEALANT OR PATCH MATERIALS, OR A COMBINATION OF SUTURE REPAIR WITH A SEALANT/PATCH. NO SPECIFIC TREATMENT WAS UTILIZED OR ABLE TO BE DETERMINED IN 14 CASES (13%). SEALANT/PATCH MATERIALS VARIED AND INCLUDED DURAGEN (INTEGRA LIFESCIENCES CO, (B)(4)), DURASEAL (COVIDIEN, (B)(4)), TISSEAL (BAXTER HEALTHCARE CO, (B)(4)), SURGICEL (ETHICON, (B)(4)), EVICEL (ETHICON, (B)(4)), SURGIFOAM (ETHICON, (B)(4)), GELFOAM (PFIZER INC, (B)(4)), AND/OR LOCAL MUSCLE. RESULT: A MAJORITY OF PATIENTS REQUIRED NO FURTHER TREATMENT FOLLOWING THE INITIAL SURGERY, WHILE 13 PATIENTS (12%) REQUIRED SUBSEQUENT INTERVENTIONS TO CONTROL CSF DRAINAGE. THERE WERE 6 CASES THAT REQUIRED A REVISION OPERATIVE DURAL REPAIR (6%), 5 CASES THAT REQUIRED DELAYED (BEYOND POSTOPERATIVE DAY 1) LUMBAR DRAIN PLACEMENT (5%), AND 2 THAT HAD BOTH A REVISION SURGERY AND LUMBAR DRAIN PLACEMENT (2%). THERE WERE 10 PATIENTS (9%) THAT HAD REVISION OPERATIONS FOR REASONS OTHER THAN RECURRENT CSF DRAINAGE, INCLUDING POSTOPERATIVE HEMATOMA, INFECTION, REVISION DECOMPRESSION, AND/OR FUSION. FOLLOWING SUCCESSFUL CONTROL OF THE CSF DRAINAGE, A MAJORITY OF PATIENTS HAD NO SYMPTOMS ATTRIBUTABLE TO THE OCCURRENCE OF THE DURAL TEAR. THERE WERE 4 PATIENTS (4%) THAT EXPERIENCED RESIDUAL EFFECTS FROM THE DURAL TEAR, AND 3 PATIENTS (3%) WHOSE OUTCOME COULD NOT BE ASCERTAINED. THE POSSIBLE RESIDUAL EFFECTS ATTRIBUTABLE TO DURAL TEAR OCCURRENCES WERE UNABLE TO BE CHARACTERIZED. CONCLUSION: IN THIS MULTICENTER STUDY, WE REPORT OUR FINDINGS ON THE LARGEST REPORTED SERIES (N ¼ 109) OF CERVICAL DURAL TEARS. IN A VAST MAJORITY OF CASES, NO SUBSEQUENT INTERVENTIONS WERE REQUIRED AND NO CLINICAL SEQUELAE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653261 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 DURASEAL| EVICEL| GELFOAM| SURGICEL| SURGIFOAM| TISSEAL