BEUDAMED
    FDA Adverse Event Summary report: N

    GRAFTON DBM

    MDR report key: 3193124 · Received June 27, 2013

    Report

    Report Number
    2246640-2013-00020
    Date Received
    June 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC)
    Product Code
    NUN
    PMA / PMN Number
    K051195
    Removal / Correction Number
    2246640-042612-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. MULTIPLE DEVICES WERE IMPLANTED DURING THE REPORTED PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(6). (B)(4). REVIEW OF THE MANUFACTURING RECORDS FOR THE SUBJECT DEVICE INDICATED THAT THE PRODUCT WAS MANUFACTURED PER PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. MEDTRONIC HAS NOT RECEIVED ANY ADDITIONAL REPORTS OF THIS NATURE INVOLVING ANY OTHER PRODUCT MANUFACTURED FROM THIS DONOR TISSUE. THE SUBJECT PRODUCT WAS PART OF THE ABOVE THERE WAS NO REPORT OF ANY POST-OPERATIVE INFECTION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: REMEDIAL ACTION OTHER TEXT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE HAD HAD ALLOGRAFT BONE VOID FILLER AND METAL INSTRUMENTATION IMPLANTED DURING A POSTERIOR CERVICAL FUSION, AND 6 WEEKS AFTER HER SURGERY, SHE DEVELOPED AND HAS HAD A RASH AND ¿LUMP¿ IN THE BACK OF HER NECK DIRECTLY OVER THE INSTRUMENTATION. PATIENT STATED SHE IS FOLLOWING UP WITH A DERMATOLOGIST TO DETERMINE IF SHE IS EXPERIENCING AN ALLERGIC REACTION. PATIENT STATED SHE DID NOT DEVELOP ANY POST-OPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293509 GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE NUN OSTEOTECH, INC. (SUBSIDIARY OF MEDTRONIC) A43110 OTSCT0833554035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CROSSLINK, BONE SCREW, ROD