THIS REPORT IS FOR AN UNKNOWN CAGE/ SPACERS: SYNCAGE/ UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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. (B)(4).
D
Patient 1
THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: DANG L, SUN Y, WANG S, PAN S, LI M, ZHANG L, & ZHANG F (2017), A NEW SOURCE OF AUTOGRAFT BONE FOR INTERBODY FUSION IN ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY: EXPERIENCE IN 893 CASES, BRITISH JOURNAL OF NEUROSURGERY, VOLUME 31, NUMBER 1, PAGES 33-38, (CHINA). THE PURPOSE OF THIS STUDY IS TO SHARE OUR EXPERIENCE OF A MODIFIED ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE WITH A NEW SOURCE OF AUTOGRAFT BONE FOR INTERBODY FUSION. BETWEEN 2008 AND 2012, 893 PATIENTS WHO UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FOR CERVICAL SPINE DISORDERS, WERE INCLUDED IN THE STUDY. THERE WERE 538 MALES AND 355 FEMALES WITH A MEAN AGE OF 52 YEARS (RANGE, 25-85 YEARS). INTERBODY CAGES AND ANTERIOR CERVICAL PLATES WERE USED. AFTER DECOMPRESSION, A CAGE WITH OPTIMAL HEIGHT WAS CHOSEN AND FILLED WITH THE BONE COLLECTED FROM VERTEBRAL OSTEOPHYTES AND REAMS BEFORE BEING TAPPED INTO THE DISC SPACE. 161 PATIENTS WERE IMPLANTED WITH AND UNKNOWN SYNTHES CERVIOS CAGE, 12 PATIENTS WERE IMPLANTED WITH AND UNKNOWN SYNTHES SYNCAGE-C, 39 PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES CERVICAL SPINE LOCKING PLATE WITH VARIABLE ANGLE PLATE, AND THE REST OF THE PATIENTS WERE IMPLANTED WITH COMPETITORS? DEVICES. NECK MOBILIZATION WAS ENCOURAGED FOR ALL PATIENTS AS SOON AS THE DRAINS WERE REMOVED 1?2 DAYS AFTER SURGERY. FOR EACH CASE, RADIOLOGICAL FUSION RATE AND CLINICAL OUTCOME WERE FOLLOWED UP FOR 3 AND 12 MONTHS AFTER SURGERY. COMPLICATIONS WERE REPORTED AS FOLLOWS: (1-LEVEL FUSION). 96 PATIENTS HAD NON-FUSION AT 3 MONTHS FOLLOW-UP. 4 PATIENTS HAD NON-FUSION AT 12 MONTHS FOLLOW-UP. (2-LEVEL FUSION). 89 PATIENTS HAD NON-FUSION AT 3 MONTHS FOLLOW-UP. 12 PATIENTS HAD NON-FUSION AT 12 MONTHS FOLLOW-UP. (3-LEVEL FUSION). 28 PATIENTS HAD NON-FUSION AT 3 MONTHS FOLLOW-UP. 6 PATIENTS HAD NON-FUSION AT 12 MONTHS FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN SYNTHES SYNCAGE-C. IT CAPTURES THE REPORTED EVENT OF NON-FUSION. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).