STRAUMANN EMDOGAIN
Received Jan 9, 2015 · Event occurred Oct 7, 2014
Report 1222315-2015-00002 · MDR key 4433297
Device
Product problems
- Patient-Device Incompatibility
Patient
46 YR
- Necrosis
- Pain
- Swelling
- Discomfort
- Impaired Healing
- Reaction
Narrative
Additional Manufacturer Narrative
THE REVIEW OF THE RISK MANAGEMENT REPORT "RISK MGMT REPORT - EMD PREFGEL OSTEOGAIN (B)(4) VERSION 1.0" CONFIRMS THAT INCAUTIOUS USE IN PATIENTS PRE-DISPOSED TO ALLERGIC REACTIONS IS ASSESSED AND REFLECTED IN THE IFU LABELLING 700019 STRAUMANN EMDOGAIN (US VERSION). A PREVIOUS EVALUATION BY AN ALLERGIST STATES THAT THE ALLERGY POTENTIAL OF EMDOGAIN IS VERY LOW. THE MANUFACTURER REVIEWED MANUFACTURING BATCH RECORDS FOR BOTH 075.114 LOT GP625 (BOTH EMDOGAIN AND PREFGEL) AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPECIFICATION.
Description of Event or Problem
CLINICIAN REPORTS LACK OF WOUND HEALING AFTER A PERIODONTAL SURGERY TO TREAT AN INTRAOSSEOUS/FURCATION DEFECT WHICH WAS PERFORMED ON (B)(6) 2014. TREATMENT SITE: FDI #21 - MP INTRABONY DEFECT (5 MM INTRABONY COMPONENT). SURGICAL TECHNIQUE WAS MINIMALLY INVASIVE. ON (B)(6) 2014 POST-OP SYMPTOMS INCLUDED SEVERE PAIN AND DISCOMFORT WITH SIGNS AS SEVERE SWELLING AND NECROSIS. THE CLINICIAN SUSPECTS AN ALLERGIC REACTION TO THE PRODUCT.