NEURAGEN 3D NERVE GUIDE MATRIX 7MM X 3CM

Description of Event or Problem

A FACILITY REPORTED A NEURAGEN NERVE GUIDE MATRIX (ID PNGM730) INNER LUMEN CAME UNATTACHED FROM THE OUTER LUMEN AND COULD NOT BE RESTORED WITH ADDITIONAL HYDRATION OR REHYDRATION. IT WAS OPENED FOR APPLICATION AND THE SIZE, TRIMMING, HYDRATION AND ATRIUM CREATION WERE ALL COMPLETED ACCORDING TO MANUFACTURER GUIDELINES. THE INNER MATRIX APPEARED TO FAIL AND DISCONNECT FROM THE OUTER LUMEN AND THE SURGEON WAS NOT SATISFIED WHEN HE COULD SEE THROUGH THE PRODUCT, SO HE WASTED THE PRODUCT AND OPENED A PNGM630, FOLLOWED ALL GUIDELINES AND IMPLANTED THE PNGM630 AFTER HE WAS SATISFIED THE INNER LUMEN WAS RESTORED AND COVERED THE ENTIRE CROSS SECTION OF THE LUMEN. THE PRODUCT WAS USED FOR A MEDIAN NERVE REPAIR, NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

NEURAGEN WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

N/A.