UNK - VERTEBRAL BODY REPLACEMENT - TITANIUM MESH

Description of Event or Problem

THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SUN, K. ET AL (2018), PLACEMENT OF TITANIUM MESH IN HYBRID DECOMPRESSION SURGERY TO AVOID GRAFT SUBSIDENCE IN TREATMENT OF THREE-LEVEL CERVICAL SPONDYLOTIC MYELOPATHY: CEPHALAD OR CAUDAL?, MEDICAL SCIENCE MONITOR, VOL. 24 (XX), PAGES 9479-9787 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE RADIOLOGICAL CHANGES IN PATIENTS WITH THREE-LEVEL CSM WHO HAD HYBRID DECOMPRESSION PROCEDURE AND ASSESSED THE EFFECT OF THE POSITION OF TM RELATIVE TO INTERVERTEBRAL CAGE (IC) ON GRAFT SUBSIDENCE. BETWEEN JANUARY 2014 AND JANUARY 2017, A TOTAL OF 48 PATIENTS (32 MALE AND 16 FEMALE) WHO UNDERWENT THREE-LEVEL HYBRID DECOMPRESSION AND FUSION WERE INCLUDED IN THE STUDY. DISCECTOMY WAS CARRIED OUT FIRST. AFTER CAREFUL REMOVAL OF DISC, POSTERIOR OSTEOPHYTE, AND OSSIFIED LONGITUDINAL LIGAMENT, AN APPROPRIATELY SIZED INTERVERTEBRAL CAGE (IC, DEPUY, USA) PACKED WITH AUTOGENOUS BONE WAS INSERTED INTO THE INTERVERTEBRAL SPACE. OF NOTE, MORE ATTENTION SHOULD BE PAID TO AVOIDING EXCESSIVE DAMAGE TO THE ENDPLATE. AFTER ADEQUATE ADJACENT DISCECTOMIES, CORPECTOMY WAS CONDUCTED BY RESECTING THREE-FIFTHS OF THE VERTEBRAL BODY. THEN, THE POSTERIOR LONGITUDINAL LIGAMENT WAS RESECTED IN EACH PATIENT TO ENSURE FULL DECOMPRESSION OF THE SPINAL CORD. AFTER BEING PACKED WITH AUTOGENOUS BONE, THE TITANIUM MESH (TM, DEPUY, USA) WAS FILLED WITH AUTOLOGOUS BONE FRAGMENTS HARVESTED FROM THE EXCISED VERTEBRA, AND THEN IMPLANTED UNDER DISTRACTION. THE DISTRACTION WAS LESS THAN 6 MM FOR TWO-LEVEL CORPECTOMY. THE TM WAS INSERTED AT TWO-THIRDS OF THE VERTEBRAL COLUMN, USUALLY 2¿3 MM TO THE VERTEBRAL ANTERIOR BORDER. A SEMICONSTRAINED CERVICAL PLATE (SKYLINE OR SLIMLOCK, DEPUY, USA) WAS USED TO BRIDGE THE FUSION SEGMENTS. ALL PATIENTS IN THIS STUDY WORE A PHILADELPHIA NECK COLLAR FOR AT LEAST 2 MONTHS. THE PATIENTS WERE DIVIDED INTO GROUP A (TM LOCATED CEPHALAD, N=21; 13 MALE AND 8 FEMALE) AND GROUP B (TM LOCATED CAUDAL, N=27; 19 MALE AND 8 FEMALE) AC¬CORDING TO THE LEVEL OF TM. THE AVERAGE FOLLOW-UP WAS 4.38±0.439 AND 4.81±0.509 MONTHS IN GROUP A AND GROUP B, RESPECTIVELY. ANTERIOR, MIDDLE, AND POSTERIOR SUBSIDENCE OF TM WERE DEFINED AS THE LOSS BETWEEN THE IMMEDIATELY POST¬OPERATIVE AND FINAL FOLLOW-UP VALUES IN AIBH, MIBH, AND PIBH, RESPECTIVELY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN 85% IN GROUP B AND 76% IN GROUP A, TITANIUM MESH SUBSIDENCE OCCURRED. IN GROUP A, THE AIBH WAS 28.73±2.541 IMMEDIATELY POSTOPERATIVELY AND 27.11±2.619 AT THE FINAL FOLLOW-UP, THE MIBH WAS 28.64±2.801 AND 26.55±2.823 AND THE PIBH WAS 27.06±2.493 AND 24.47±2.497. IN GROUP B, THE AIBH/MIBH/PIBH WAS 29.34±1.885/29.35±1.947/27.06±2.655 IMMEDIATELY POSTOPERATIVELY AND 28.49±2.068/28.35±2.149/ 25.73±2.566 AT THE FINAL FOLLOW-UP. THE DIFFERENCES IN AIBH/MIBH/PIBH BETWEEN THE 2 GROUPS AT THE FINAL FOLLOW-UP WERE SIGNIFICANT (P<0.05). THE INDEX LOSS OF ANTERIOR (AIBH), MIDDLE (MIBH), AND POSTERIOR INTERBODY HEIGHT (PIBH) IN GROUP A WAS 0.857±0.448/1 1.33±0.60/8.00±0.525, RESPECTIVELY, ALL LOWER THAN THAT IN GROUP B (P<0.05). 3 PATIENTS IN GROUP B HAD SEVERE TM SUBSIDENCE AT THE FINAL FOLLOW-UP, INCLUDING 2 CASES WITH FUSION OF C3-C6 AND 1 CASE WITH FUSION OF C4¿C7. - A 47-YEAR-OLD FEMALE PATIENT WHO HAD SEVERE TM SUBSIDENCE AND GRAFT MIGRATION AT 7 MONTHS POSTOPERATIVELY (FIG 3). - A 45-YEAR-OLD MALE PATIENT WHO HAD SIGNIFICANT TM SUBSIDENCE SEEN IN THE LATERAL RADIOGRAPH AT THE FINAL FOLLOW-UP OF 6 MONTHS (FIG 4). THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE VERTEBRAL BODY REPLACEMENT - TITANIUM MESH. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 4 OF 4 FOR (B)(4)..

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY REPLACEMENT - TITANIUM MESH/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. H6 COMPONENT CODE: G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) USED TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.