BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM 21S

    MDR report key: 1594519 · Received January 25, 2010

    Report

    Report Number
    2410375-2009-00011
    Event Type
    Injury
    Date Received
    January 25, 2010
    Date of Event
    January 1, 2009
    Report Date
    January 15, 2010
    Product Code
    NPZ
    PMA / PMN Number
    P040013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INITIAL SPONTANEOUS REPORT ASSESSED AS NON-SERIOUS WAS RECEIVED ON 12/29/2009 FROM AN ORAL SURGEON REGARDING GEM-21S CONCERNING A (B) (6) MALE. ON 01/08/2010, THE FOLLOWING ADD'L DETAILS WERE RECEIVED IN WHICH THE REPORT WAS ASSESSED BY LUITPOLD PHARMACEUTICALS INC AS SERIOUS. THE PT WAS REPORTED AS HAVING NO PRE-EXISTING MEDICAL HISTORY WITH NO CONCOMITANT MEDICATION HISTORY. THE PT HAD A DENTAL HISTORY OF ALVEOLAR WIDTH INSUFFICIENCY RELATIVE TO IMPLANT PLACEMENT. ON (B) (6) 2009, THE PT UNDERWENT A BONE GRAFT OF THE LEFT POSTERIOR MANDIBLE IN WHICH THE PRACTITIONER EMPLOYED A MIXTURE OF GEM-21S (LOT # PC0081, EXP DATE 04/2010) WITH ALLOGENEIC, AUTOLOGOUS AND CANCELLOUS BONE (OFF LABEL METHOD OF USE). THE GEM-21S WAS REPORTED AS SINGLE USE. INTRAOPERATIVE MEDICATIONS INCLUDED FENTANYL AND CLINDAMYCIN 600 MG. (ROUTES NOT SPECIFIED). THE PT WAS PRESCRIBED A POST OPERATIVE COURSE OF CLINDAMYCIN AND ORAL VICODIN. ON (B) (6) 2009, THE PT CONTACTED THE PRACTITIONER TO REPORT THAT THE INCISION SITE HAD OPENED UP. AN OFFICE VISIT THE SAME DAY CONFIRMED DEHISCENCE OF THE SURGICAL INCISION (MEDDRA CODED AS WOUND DEHISCENCE). THE PRACTITIONER REPORTED THAT THE TISSUE SURROUNDING THE SURGICAL SITE HAD A HARD, FIBROTIC APPEARANCE (MEDDRA CODED AS SOFT TISSUE DISORDER). TREATMENT INCLUDED MINIMAL DEBRIDEMENT OF FIBROTIC TISSUE AND LOOSE SURFACE BONE WITH INSTRUCTION TO CONTINUE SOFT DIET AND PERIDEX ORAL RINSE. A F/U EXAM ON (B) (6) 2009 REVEALED FURTHER DEHISCENCE OF THE SURGICAL SITE. TREATMENT CONTINUED WITH A SOFT DIET AND PERIDEX; THE ANTIBIOTIC WAS CHANGED TO FLAGYL. ON (B) (6) 2009, THE PT WAS SEEN FOR F/U; NO IMPROVEMENT WAS NOTED. OVER A PERIOD OF 6 MONTHS, THERE WERE SPOTTY 1 CM AREAS OF FORMATION OF GRANULATION TISSUE AT THE SURGICAL SITE, BUT THE WOUND NEVER CLOSED (MEDDRA CODED AS IMPAIRED HEALING). NO SIGNS OF INFECTION WERE NOTED DURING THIS TIME. SURGICAL CLOSURE OF THE WOUND WAS SCHEDULED (B) (6) 2009. THE ORAL SURGEON REMOVED WHAT WAS DESCRIBED AS BONE THAT FAILED TO INTEGRATE AND DEBRIDED AREAS OF HARD FIBROTIC TISSUE. THE WOUND HAS SINCE REMAINED CLOSED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM 21S NONE NPZ PC0081

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention