UNK - CAGE/SPACER: CONDUIT EIT

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KIM DH, KIM SD, KIM JY, HONG JT, HUR JW. COMPARISON OF ANTERIOR CERVICAL DISCECTOMY AND FUSION USING A NOVEL 3D-PRINTED POROUS TITANIUM CAGE VERSUS CONVENTIONAL ALLOGRAFT BONE BLOCK WITH PLATE AND SCREW SYSTEM: A PROPENSITY-MATCHED COHORT STUDY. NEUROL INDIA. 2026 MAY 1;74(3):418-423. DOI: 10.4103/NEUROL-INDIA.NEUROL-INDIA-D-25-00713. EPUB 2026 MAY 6. PMID: 42087635. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO COMPARE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF SINGLE-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) USING STAND-ALONE 3D PRINTING TECHNOLOGY, POROUS TITANIUM CAGES (3D-PTCS) WITH THOSE OF CONVENTIONAL ACDF EMPLOYING AN ALLOGRAFT BONE BLOCK AND PLATE/SCREW SYSTEM, WITH A MINIMUM FOLLOW-UP DURATION OF 24 MONTHS. MEDICAL RECORDS OF PATIENTS WHO UNDERWENT ACDF BETWEEN DECEMBER 2016 AND JANUARY 2018 WERE RETROSPECTIVELY REVIEWED. PATIENTS WHO UNDERWENT SINGLE-LEVEL STAND-ALONE ACDF USING 3D-PTCS FOR CDD BETWEEN THE C3 AND C7 LEVELS WERE IDENTIFIED. THE 3D-PTC SPACERS USED (CONDUIT¿/EIT¿ CELLULAR TITANIUM, DEPUY SYNTHES, MA, USA) HAD >80% POROSITY, A PORE SIZE OF 650 ¿M, AND A ROUGH NANOSURFACE. FOR THE CONTROL GROUP, CONVENTIONAL ACDF WAS PERFORMED USING AN ALLOGRAFT BONE BLOCK (C-PLUS¿, CGBIO, KOREA) WITH SUPPLEMENTARY ANTERIOR PLATING (TRISECURE¿, CGBIO, KOREA) FOLLOWING THE SAME SURGICAL TECHNIQUE. THIRTY PATIENTS (17 MALES & 13 FEMALES; MEAN AGE: 54.4 (± 8.7)) WHO UNDERWENT SINGLE-LEVEL ACDF USING 3D-PTCS WERE ASSIGNED TO THE PTC GROUP. PATIENTS IN THE PTC GROUP WERE MATCHED ONE-TO-ONE WITH THIRTY CONTROL PATIENTS FROM THE ACDF GROUP BASED ON AGE, SEX, AND SURGICAL LEVEL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES CONDUIT¿/EIT¿ CELLULAR TITANIUM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CAGE/SPACER: CONDUIT EIT (QTY 10): (N=10) SUBSIDENCE; NO TREATMENT REPORTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.