BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7812672 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00039
    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

    NO COMPLAINT UNIT WILL BE RETURNED AND NO FAILURE ANALYSIS IS POSSIBLE SINCE THIS COMPLAINT CORRESPOND TO A STUDY PUBLISHED IN 2014 THAT PERFORMED A RETROSPECTIVE EVALUATION BETWEEN 2004 TO 2014. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED DURING THE RETROSPECTIVE EVALUATION, IT IS UNABLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND THEREFORE, WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND EVENT/NC/CAPA/SCAR HISTORY REVIEW. THUS, THE REPORTED CONDITION IS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED CONDITION IS UNDETERMINED. LINKED TO MFG REPORT NUMBER: 1121308-2018-00040. DOI: 10.1007/S00381-016-3300-2.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS: CHILD'S NERVOUS SYSTEM (2017) PUBLISHED "EXTERNAL VALIDITY OF THE CHIARI SEVERITY INDEX AND OUTCOMES AMONG PEDIATRIC CHIARI I PATIENTS TREATED WITH INTRA- OR EXTRA-DURAL DECOMPRESSION" IN WHICH IN THIS STUDY EVALUATES THE RESULTS OF INTRADURAL (ID) VERSUS EXTRADURAL (ED) DECOMPRESSION AND ASSESS THE EXTERNAL VALIDITY OF THE CSI. A RETROSPECTIVE COHORT STUDY OF PEDIATRIC CM-1 PATIENTS UNDERGOING DECOMPRESSION AT A SINGLE ACADEMIC CHILDREN¿S HOSPITAL WAS PERFORMED. CHARACTERISTICS OF HEADACHE, SYRINX, AND MYELOPATHY WERE COLLECTED TO DERIVE CSI GRADE. THE PRIMARY OUTCOME MEASURE WAS PRE-OPERATIVE SYMPTOM RESOLUTION. THE PROPORTION OF PATIENTS WITH FAVORABLE OUTCOME WAS TABULATED FOR EACH OF THE THREE CSI GRADES AND COMPARED TO PREVIOUSLY PUBLISHED RESULTS. ONE OF THREE SURGEONS PERFORMED ALL SURGERIES IN THE STUDY PATIENTS. SELECTION OF THE ID VERSUS ED SURGICAL APPROACH WAS MADE BASED ON THE CLINICAL JUDGMENT OF THE INDIVIDUAL SURGEON. IN EACH CASE, THE PATIENT WAS POSITIONED PRONE, AND A MIDLINE INCISION WAS MADE FROM THE OCCIPUT TO THE C2 SPINOUS PROCESS. A SUBOCCIPITAL CRANIECTOMY AND C1 LAMINECTOMY WAS COMPLETED. A PORTION OF C2 WAS REMOVED IN CASES IN WHICH THE TONSIL EXTENDED BEYOND THAT LEVEL. IN ALL CASES, THE ATLANTO-OCCIPITAL LIGAMENT WAS SHARPLY INCISED. FOR THE ID APPROACH, THE DURA WAS OPENED IN A Y-SHAPE. ALLODERM OR ALLOGRAFT WAS SEWN IN OR DURAGEN (INTEGRA, (B)(4)) WAS PLACED AS AN OVERLAY FOR DURAL RECONSTRUCTION. FOR THE ED APPROACH, A VERTICAL, PARTIAL-THICKNESS CUT WAS MADE IN THE DURA AND EXTENDED LATERALLY. THE INNER DURAL LEAFLET AND ARACHNOID WERE NOT ENTERED IN THE ED APPROACH. FOR BOTH APPROACHES, HEMOSTASIS WAS OBTAINED AND THE WOUND WAS CLOSED IN LAYERS. CONVERSION FROM AN ED TO ID APPROACH, WHEN IT OCCURRED, WAS BASED ON AN INTRA-OPERATIVE DECISION BY THE SURGEON. PATIENTS FOR WHICH ED APPROACH WAS CONVERTED TO ID APPROACH WERE SUBSEQUENTLY ANALYZED AS ID PATIENTS. ALL THREE SURGEONS FOLLOWED SIMILAR POST-OPERATIVE CARE PROTOCOLS, WHICH DID NOT INCLUDE PROPHYLACTIC STEROID ADMINISTRATION FOLLOWING ID DECOMPRESSION. RESULTS: OF THE 289 CASES OF CHIARI DECOMPRESSION IDENTIFIED IN THE INSTITUTIONAL DATABASE BETWEEN THE YEARS OF 2004 AND 2014, 189 PATIENTS SATISFIED INCLUSION AND EXCLUSION CRITERIA AND WERE INCLUDED FOR ANALYSIS. COMPLICATIONS: ED; NEED FOR REOPERATION - 8; WOUND INFECTION - 3; DEATH -2. ID: NEED FOR REOPERATION - 7; PSEUDOMENINGOCELE - 16; CHEMICAL MENINGITIS - 9; WOUNED INFECTION - 1; DEATH -1. CONCLUSION: EQUIVALENT RATES OF SYMPTOM RESOLUTION AND REOPERATION FOLLOWING ID AND ED DECOMPRESSION SUPPORT THE ED APPROACH AS A FIRST-LINE SURGICAL OPTION FOR PEDIATRIC CM- 1 PATIENTS. IN ADDITION, THE FINDINGS PROVIDE PRELIMINARY EVIDENCE SUPPORTING THE GENERALIZABILITY OF THE CSI AND ITS USE IN FUTURE COMPARATIVE TRIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653262 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLODERM| ALLOGRAFT