UNK - RESORBABLE IMPLANTS: MESH

Additional Manufacturer Narrative

(B)(4). THIS REPORT IS FOR AN UNK - RESORBABLE IMPLANTS: MESH. UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZHAO Y, LI Z, DENG Y (2020), DELAYED ORBITAL APEX SYNDROME IN THE POST-RECONSTRUCTED ORBIT, THE JOURNAL OF CRANIOFACIAL SURGERY, VOLUME 31, NUMBER 5, PAGES E481-E483 (CHINA) THIS REPORT IS TO PRESENT A CASE OF DELAYED ORBITAL APEX SYNDROME (OAS) SECONDARY TO A DISPLACED IMPLANT AND EMPHYSEMA IN POST-RECONSTRUCTED ORBIT. A (B)(6) FEMALE HAD A FACIAL TRAUMA FOLLOWING A FALL. HER RIGHT EYE EXHIBITED 3MM ENOPHTHALMOS 2 WEEKS LATER. OPHTHALMOLOGICAL EXAMINATION SHOWED DIPLOPIA AND EYE MOVEMENT LIMITATION ON UPPER GAZE WITH FACIAL NUMBNESS. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED THE FLOOR WALL FRACTURE OF THE RIGHT ORBIT AND HERNIATION OF SOFT TISSUE. THE PATIENT UNDERWENT ORBITAL WALL RECONSTRUCTION UNDER GENERAL ANESTHESIA. THE INCARCERATED TISSUES WERE RETURNED BY TRANSCONJUNCTIVAL APPROACH. THE UNKNOWN SYNTHES RAPIDSORB ORBFLOOR MESH WAS IMPLANTED TO TOTALLY COVER THE FLOOR DEFECTS DURING THE OPERATION. THE OCULAR MOTILITY AND ENOPHTHALMOS WERE IMPROVED DURING THE POSTOPERATIVE PERIOD, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POSTOPERATIVE DAY 3. AFTER SEVERE SNEEZING ON POSTOPERATIVE DAY 10, THE PATIENT GRADUALLY AROSE VISION LOSS, PTOSIS WITH A DILATED AND FIXED PUPIL, LIMITED EYE MOVEMENTS ON ALL DIRECTIONS OF OD WITHIN FEW HOURS. RIGHT EYE SHOWED A RELATIVE AFFERENT PUPILLARY DEFECT (RAPD). FURTHER CT SCAN SHOWED RETROBULBAR EMPHYSEMA AND DISPLACED IMPLANT RESULTING IN UPWARD MIGRATION OF INFERIOR RECTUS AND EXTRUSION OF THE OPTIC NERVE. AXIAL CT SHOWED THE SWOLLEN POSTERIOR SEGMENT OF THE MEDIAL RECTUS AGGRAVATED THE COMPRESSION OF ORBITAL APEX. THE INFERIOR ORBITOPALPEBRAL EMPHYSEMA FURTHER MANIFESTED A PREVIOUS INCREASED INTRAORBITAL PRESSURE MAY BE DUE TO NASAL BLOWING OR SNEEZE. THE PATIENT WAS DIAGNOSED WITH ORBITAL APEX SYNDROME, LIKELY SECONDARY TO DISPLACED IMPLANT AND INTRAORBITAL EMPHYSEMA. AN EXPLORATORY SURGERY WAS DONE TO REPOSITION THE IMPLANT AND REDUCE THE EMPHYSEMA BY THE PRIOR INCISION. EXCEPT FOR THE SWOLLEN MEDIAL AND INFERIOR RECTUS, NO HEMORRHAGIC MASS WAS FOUND IN RETROBULBAR OR ORBITAL APEX. THE PATIENT PARTIALLY REGAINED VISION AT NEXT DAY. POSTOPERATIVE CT SCAN ON DAY 3 SHOWED THAT DISPLACEMENT OF THE IMPLANT WAS CORRECTED, AND THE EMPHYSEMA, THE MIGRATION OF MEDIAL RECTUS MUSCLE AND COMPRESSION OF OPTIC NERVE WERE RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POSTOPERATIVE DAY 5. ONE MONTH LATER, THE PATIENT COULD OPEN RIGHT EYE AND ROTATE EYEBALL PROGRESSIVELY IN ALL DIRECTIONS, THE PATIENT¿S VISION WAS 20/25 OD WITH A 2-MM DISCREPANCY IN PUPILLARY SIZE. AT THE 6 MONTHS FOLLOW-UP, ALL SYMPTOMS HAD RESOLVED. THIS REPORT IS FOR THE UNKNOWN SYNTHES RAPIDSORB ORB FLOOR MESH. THIS REPORT IS FOR (1) UNK - RESORBABLE IMPLANTS: MESH. THIS REPORT IS 1 OF 1 FOR (B)(4).