BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 4

    MDR report key: 5627563 · Received May 3, 2016

    Report

    Report Number
    1121308-2016-00010
    Event Type
    Injury
    Date Received
    May 3, 2016
    Report Date
    April 8, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K043427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 05AUG2016. DEVICE HISTORY RECORD OF THE FINISHED GOOD (FG) LOTS # 1143877 (MFG DATE: 10/10/14; EXP. DATE: 2016-10), 1152764 (MFG DATE: 07/14/15; EXP. DATE: 2017-07), AND 1152325 (MFG DATE: 06/12/15; EXP. DATE: 2018-06) WERE REVIEWED. THESE FG LOTS ORIGINATE FROM (B)(4) AT LOTS 105000310550, 105000326396 AND 105000311559 RESPECTIVELY. ACCORDING TO THE DHR REVIEW CONDUCTED FOR FG LOTS 1143877, 1152764 AND 1152325 THERE IS NO INDICATION THAT THE PRODUCTION PROCESS OF THIS LOT CONTRIBUTED TO THE COMPLAINT EVENT. NO ANOMALIES WERE REPORTED DURING THE MANUFACTURING AND PACKAGING PROCESSES OF THESE LOTS THAT COULD BE RELATED TO THE REPORTED CONDITION. NONCONFORMANCES (NCR), SCAR¿S AND CAPA REPORTS WERE ALSO REVIEWED BUT NO SIMILAR CONDITIONS HAVE BEEN REPORTED SINCE APRIL 2014 ON DURAGEN PLUS FAMILY OR SUTURABLE DURAGEN FAMILY. AS PER CUSTOMER, THE DEVICE WAS NOT GOING TO BE RETURNED FOR EVALUATION. HOWEVER, RETAIN SAMPLE VISUAL EVALUATION WAS CONDUCTED. FOUR (4) RETAIN SAMPLE OF FG LOT 1143877, EIGHT (8) RETAIN SAMPLE OF FG LOT 1152764 , AND FIVE (5) RETAIN SAMPLE OF FG LOT 1152325 WERE VISUALLY INSPECTED FOR SIGNS OF DETERIORATION. NO SIGNS OF DETERIORATION WERE FOUND DURING THE RETAIN SAMPLE VISUAL EVALUATION. AFTER REVIEWING THE COMPLAINT SYSTEM SINCE APRIL 2014, FIVE (5) COMPLAINTS (INCLUDING THE ONE BEING INVESTIGATED) RELATED TO THE CONDITION DESCRIBED HAVE BEEN REPORTED ON DURAGEN FAMILY. APPROXIMATELY (B)(4) UNITS OF DURAGEN PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES SINCE 04/15/14. AS OF 04/15/16, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). THE REPORTED CONDITION COULD NOT BE CONFIRMED BASED ON THE DHR REVIEW AND THE INFORMATION PROVIDED BY THE REPORTING FACILITY AND DOCUMENTED IN THE COMPLAINT SYSTEM PARENT RECORD. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A DEFINITE ROOT CAUSE FOR THE REPORTED CONDITION AT THIS TIME. NO ASSIGNABLE CAUSES THAT COULD BE ASSOCIATED TO THE DURAGEN MANUFACTURING OR PACKAGING PROCESS BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD (DHR), SCAR¿S, CAPA¿S AND NCR¿S HISTORY.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF THREE REPORTS (SAME REPORTER, SAME PRODUCT FAMILY, DIFFERENT PRODUCT IDS, DIFFERENT LOT NUMBERS). THIS IS IN REGARDS TO PATIENT 1 (DURAGEN LOT NUMBER 1143877). LINKED TO MFG REPORT NUMBER: 1121308-2016-00012 (SAME PATIENT). LINKED TO MFG REPORT NUMBER: 1121308-2016-00011 (SIMILAR PRODUCT, DIFFERENT PATIENT). INITIALLY IT WAS REPORTED THAT THREE PATIENTS HAVE DEVELOPED INFECTIONS AND THE ONLY COMMONALITY WAS ALL THREE PATIENTS HAVE HAD DURAGEN IMPLANTED. THE CUSTOMER WAS NOT SURE IF THE PRODUCT WAS IMPACTING THE PATIENTS AND IF IT WAS CAUSING INFECTIONS BUT THE CUSTOMER WANTED TO RULE IT OUT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 20APR2016: THE CUSTOMER VERIFIED THAT THIS ONLY OCCURRED IN TWO PATIENTS AND THE PATIENT THAT RECEIVED TWO PATCHES HAD DURAGEN WITH LOT NUMBERS 1143877 AND 1152325. BOTH PATIENTS WERE MALES IN 40'S THAT HAD CRANIOTOMIES. AS PER CUSTOMER, NO FURTHER INFORMATION WILL BE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284144 DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 4 N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1143877

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other