UNK - RESORBABLE IMPLANTS: MESH

Additional Manufacturer Narrative

510K: 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: JUNG J.S., KANG D.H., LIM N.K., KIM H., (2020)ORBITAL WALL RESTORATION WITH PRIMARY BONE FRAGMENTS IN COMPLEX ORBITAL FRACTURES: A PRELIMINARY STUDY, ARCH CRANIOFAC SURG VOL.21 NO.3, 156-160 (KOREA, SOUTH) HTTPS://DOI.ORG/10.7181/ACFS.2020.00101. THIS STUDY AIMS TO EVALUATE 23 PATIENTS WHO UNDERWENT COMPLEX ORBITAL WALL RESTORATION USING PRIMARY BONE FRAGMENTS WITH AN UNEVENTFUL POSTOPERATIVE COURSE AND FAVORABLE OUTCOMES. BETWEEN 2012 AND 2019, 23 PATIENTS (21 MALES, 2 FEMALES) WITH COMPLEX ORBITAL WALL FRACTURES WHO WERE TREATED WITH THE STANDARD OPEN REDUCTION METHOD USING THE TRANSNASAL AND TRANSORBITAL APPROACHES WERE INCLUDED IN THE STUDY. BONY RESTORATION WAS DONE BY PLACING A POROUS POLYETHYLENE IMPLANT SUCH AS SYNPOR (SYNTHES INC., WEST CHESTER, PA, USA) OR MEDPOR (POREX SURGICAL INC., NEWNAN, GA, USA) OR A RESORBABLE MESH PLATE SUCH AS RAPIDSORB (SYNTHES INC.) TO BRIDGE THE REMAINING DEFECT.FOLLOW-UP WAS PERFORMED 6 MONTHS AFTER TREATMENT. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: SHORT TERM COMPLICATIONS INCLUDED SOFT-TISSUE INFECTIONS IN TWO PATIENTS. THIS REPORT IS FOR AN UNKNOWN SYNTHES POROUS POLYETHYLENE IMPLANT SYNPOR AND UNKNOWN SYNTHES RESORBABLE MESH PLATE RAPIDSORB. THIS REPORT IS FOR ONE (1) UNK - RESORBABLE IMPLANTS: MESH. THIS IS REPORT 2 OF 3 FOR (B)(4).