UNK - CAGE/SPACER: BENGAL

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG C, LIU S, YUAN J, SHI Z. COMPARISON BETWEEN PLATE CAGE SYSTEM AND STAND-ALONE CAGE IN THE TREATMENT OF CERVICAL SPONDYLOTIC MYELOPATHY PATIENTS WITH CERVICAL KYPHOSIS: CLINICAL AND RADIOGRAPHIC OUTCOMES. FRONT SURG. 2026 FEB 18;13:1749161. DOI: 10.3389/FSURG.2026.1749161. PMID: 41788356; PMCID: PMC12957233. OBJECTIVE/METHODS/STUDY DATA: THE CURRENT STUDY AIMS TO EVALUATE AND CONTRAST THE CLINICAL AND RADIOLOGICAL OUTCOMES OBSERVED IN CERVICAL SPONDYLOTIC MYELOPATHY (CSM) PATIENTS WITH CERVICAL KYPHOSIS WHO UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH EITHER A STAND-ALONE CAGE OR A PLATE CAGE SYSTEM. THEY RETROSPECTIVELY REVIEWED CSM PATIENTS WITH CERVICAL KYPHOSIS AT THEIR INSTITUTION FROM MAY 2019 TO APRIL 2021. A TOTAL OF 130 PATIENTS (63 MEN, 67 WOMEN) UNDERWENT TWO-LEVEL ACDF WITH EITHER STAND-ALONE CAGES (SA GROUP, N = 64; 31 MALES AND 33 FEMALES; MEAN AGE: 63.4) OR PLATE-CAGE SYSTEMS (PC GROUP, N = 66; 34 MALES AND 32 FEMALES; MEAN AGE: 63.7). IN THE SA GROUP, STAND-ALONE CAGES WITH INTEGRATED SCREW FIXATION (ZERO-P, DEPUY SYNTHES) WERE IMPLANTED, WHEREAS THE PC GROUP RECEIVED POLYETHERETHERKETONE (PEEK) INTERBODY CAGES (SKYLINE, DEPUY SYNTHES) COMBINED WITH ANTERIOR CERVICAL PLATING SYSTEMS (BENGAL, DEPUY SYNTHES). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES SKYLINE & BENGAL. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS (QTY 29): (N=20) DYSPHAGIA; NO TREATMENT REPORTED; (N=1) CEREBRAL FLUID LEAKAGE; NO TREATMENT REPORTED; (N=1) EPIDURAL HEMATOMA; NO TREATMENT REPORTED; (N=2) SUBCUTANEOUS HEMATOMA; NO TREATMENT REPORTED; (N=1) WOUND INFECTION; NO TREATMENT REPORTED; (N=1) HORNER SYNDROME; NO TREATMENT REPORTED; (N=3) HOARSENESS; NO TREATMENT REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CAGE/SPACER: BENGAL (QTY 29): (N=20) DYSPHAGIA; NO TREATMENT REPORTED; (N=1) CEREBRAL FLUID LEAKAGE; NO TREATMENT REPORTED; (N=1) EPIDURAL HEMATOMA; NO TREATMENT REPORTED; (N=2) SUBCUTANEOUS HEMATOMA; NO TREATMENT REPORTED; (N=1) WOUND INFECTION; NO TREATMENT REPORTED; (N=1) HORNER SYNDROME; NO TREATMENT REPORTED; (N=3) HOARSENESS; 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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.