MEMBRAGEL
Received Sep 17, 2010
Report 1222315-2010-00013 · MDR key 1845889
Device
Product problems
- Insufficient Device Problem Information
Patient
47 YR
- Abscess
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
MANUFACTURER COMPLETED REVIEW OF THE MANUFACTURING RECORDS AND FOUND THE PRODUCT TO BE WITHIN SPECIFICATION.
Description of Event or Problem
CLINICIAN REPORTS THAT MEMBRAGEL WAS USED IN A LATERAL RIDGE AUGMENTATION PROCEDURE ON (B)(6)2010 TO TREAT A SINGLE TOOTH WIDTH DEFECT AT SITE #20 (NO VERTICAL DEFECT). PT PRESENTED WITH AN INFECTION WHILE TRAVELING ON VACATION TO ARIZONA. ANTIBIOTICS FOR ONE WEEK WERE PRESCRIBED BY A LOCAL ORAL SURGEON. PT RETURNED TO INITIAL TREATING SURGEON. AT THIS VISIT PIECES OF MEMBRAGEL ALONG WITH PUS WERE EXPELLED UPON PRESSURE. ADDITIONAL ANTIBIOTICS WERE PRESCRIBED AND ANOTHER FOLLOW-UP SCHEDULED AFTER 1 WEEK. AT 2 WEEK POINT INFECTION HAD SIGNIFICANTLY DECREASED. SITE #20 WAS OPENED BY CLINICIAN AND THE REMAINING BITS OF MEMBRAGEL REMOVED. INFECTION HAS SUBSIDED AND THE IMPLANT IS STABLE.