BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAFORM DURAL GRAFT IMPLANT 3X3 INCHES

    MDR report key: 7438568 · Received April 17, 2018

    Report

    Report Number
    2023988-2018-00012
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 13, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GXQ
    UDI-DI
    10886704036739
    PMA / PMN Number
    K152481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED 11JUNE2018: LOT NUMBER UNKNOWN. THREE ATTEMPTS WERE MADE BY CODMAN TO TRY TO OBTAIN THE PRODUCT FOR EVALUATION. 22MAY2018: PRODUCT STATUS CHANGED TO: SAMPLE DISCARDED. THERE WAS NO SURGICAL DELAY REPORTED. NATUS COMPLETED THEIR INVESTIGATION ON 07JUNE2018. INVESTIGATION RESULTS FORWARDED BY CODMAN ON 11JUNE2018 INCLUDED THE FOLLOWING: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. INVESTIGATION SUMMARY: AS REPORTED BY THE OUS AFFILIATE, THE PATIENT DEVELOPED AN INFECTION AFTER DURAFORM WAS USED DURING A SURGERY. A REVISION SURGERY WAS PERFORMED. THE LOT NUMBER IS UNKNOWN. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. A REVIEW OF COMPLAINT RECORDS FOR THE PREVIOUS 12 MONTHS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE MOST RECENT COMPLAINT AND SMT PRESENTATION WAS REVIEWED AND DID NOT SHOW THAT THIS PRODUCT FAMILY EXCEEDED ITS UPPER CONTROL LIMIT FOR COMPLAINTS. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. INVESTIGATION METHODS/EVALUATION RESULTS: COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. ROOT CAUSE CATEGORY: UNDETERMINED : INSUFFICIENT INFORMATION FAILURE CODE CODMAN : PRODUCT ANALYSIS : DEVICE NOT RETURNED ROOT CAUSE DESCRIPTION COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. NO FURTHER CORRECTIVE & PREVENTATIVE ACTIONS PROPOSED. NO CORRECTIVE ACTION REQUIRED BASED ON THE ABOVE EVALUATION. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. THIS COMPLAINT IS NOW DEEMED CLOSED.

    Additional Manufacturer Narrative · 0

    CORRECTED: EVENT DATE (EVENT DATE IS ON (B)(6) 2018 AND NOT ON (B)(6) 2017). ADDITIONAL INFORMATION: CROSS REFERENCE MDR#: 2023988-2018-00013 (2 MDRS FILED, BECAUSE 2 DIFFERENT PART NUMBERS WERE PROVIDED BY THE USER FACILITY).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED ON A SPREADSHEET WHICH NATUS RECEIVED FROM CODMAN ON 19MARCH2018: "A PATIENT DEVELOPED AN INFECTION AFTER DURAFORM WAS USED AND A REVISION SURGERY WAS PERFORMED." EVENT DATE: (B)(6). UNK A SURGEON REVISED A SURGERY AFTER SEVERAL DAYS OF INITIAL SURGERY DUE TO INFECTION. THEY FOUND DURAFORM WAS INFECTED BY CERTAIN TYPES OF BACTERIA. HE SAID HE SAW SEVERAL CASES OF INFECTION ON DURAFORM. SURGEON FEELS THAT THE DEVICE CONTRIBUTED TO THE PROBLEM. DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281594 DURAFORM DURAL GRAFT IMPLANT 3X3 INCHES DURA SUBSTITUTE GXQ CODMAN & SHURTLEFF, INC. 80-1478 N/A 10886704036739

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R