BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM 215

    MDR report key: 2754659 · Received September 20, 2012

    Report

    Report Number
    2410375-2012-00002
    Event Type
    Injury
    Date Received
    September 20, 2012
    Report Date
    September 18, 2012
    Manufacturer
    LUITPOLD PHARMACEUTICALS, INC.
    Product Code
    NPZ
    PMA / PMN Number
    P040013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED FROM THE DENTAL PROVIDER WHO DID NOT HAVE THE MEDICAL RECORD AVAILABLE AT THE TIME OF THE CALL. THIS INVOLVED A MALE IN THE (B)(6) RANGE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT KNOWN. THE PATIENT HAD A LARGE ANTERIOR DEFECT OF TOOTH #7 REQUIRING BULK TISSUE IN THAT AREA OF PREPARATION FOR A BRIDGE. ON AN UNSPECIFIED DATE GEM 215 WAS PLACED ALONG WITH A "CT GRAFT" (CONNECTIVE TISSUE GRAFT) (MEDRA CODED OFF LABEL USE). THE PATIENT DID WELL FOR THE NEXT 5 DAYS AND THEN SWELLING DEVELOPED (AREA NOT SPECIFIED). ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT WAS FOLLOWED EVERY 3 DAYS. APPROXIMATELY 10 DAYS LATER THERE WAS AN ABSCESS AND THE CT GRAFT HAD SLOUGHED. TWO WEEKS FOLLOWING THE PROCEDURE, THE DENTAL PROVIDER REQUESTED THE PATIENT HAVE A FULL RANGE OF BLOOD WORK COMPLETED. RESULTS, SHE REPORTED, WERE "BASICALLY NORMAL" WITH THE EXCEPTION OF AN ELEVATED GLUCOSE LEVEL. THE PATIENT WAS NOT KNOWN TO HAVE A HISTORY OF DIABETES AND WAS QUESTIONED BY THE DENTAL PROVIDER ABOUT THE ABNORMAL LAB VALUE. IN FOLLOW UP THE PATIENT REPORTED THAT HE HAD EATEN A DONUT PRIOR TO SUBMITTING BLOOD FOR THE LAB WORK. AS OF (B)(6) 2012, THE PATIENT WAS 4-5 WEEKS POST PROCEDURE AND REPORTEDLY HAD COMPLETELY HEALED. HOWEVER, THE DENTAL PROVIDER REPORTED, "THE VOID IS TWICE AS LARGE". THERE HAS BEEN BONE LOSS AND TISSUE LOSS. TREATMENT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A SPONTANEOUS REPORT WAS RECEIVED BY LUITPOID PHARMACEUTICALS INC. VIA THE ADF LINE FROM A DENTAL PROVIDER INVOLVING GEM 215. THE DENTAL PROVIDER STATED SHE HAD AN ADVERSE SURGICAL OUTCOME WITH GEM 215. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM 215 NONE NPZ LUITPOLD PHARMACEUTICALS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention