EIT CIF cage CUI8060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04260557770566), received between Nov 4, 2022 and Apr 3, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Migration

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR DEVICE MALFUNCTION & CAGE SUBSIDENCE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 17 OCT 2024 DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: C5-C6, C6-C7. TREATMENT/IMPACT: NO INFORMATION PROVIDED DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: CUI8060S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: CAGE DESCRIPTION: EIT CIF CAGE, H 6MM, 8°, S. CATALOG NUMBER: NO INFORMATION PROVIDED LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: PEDICLE SCREWS AND RODS DESCRIPTION: SCREW BONE 18MM 3.5MM SELF DRILL VARIABLE ANGLE.

  Patient problems: Insufficient Information

  MAUDE report 24776547 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DRAINAGE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: PROBABLE DATE OF EVENT: 1 OCT 2025 DATE OF IMPLANT: (B)(6)) 2024 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: C3-C4, C4-C5, C5-C6, C6-C7. TREATMENT/IMPACT: ORAL/TOPICAL MEDICATION TRUE SPECIFY: TOPICAL ANTISEPTIC AND TEGADERM, REOPERATION ON (B)(6) 2025 TO ADD PUTTY BONEGRAFT.

  Patient problems: Fluid Discharge

  MAUDE report 23498561 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DRAINAGE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: PROBABLE DATE OF EVENT: 1 OCT 2025 DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: C3-C4, C4-C5, C5-C6, C6-C7 TREATMENT/IMPACT: ORAL/TOPICAL MEDICATION TRUE SPECIFY: TOPICAL ANTISEPTIC AND TEGADERM, REOPERATION ON (B)(6) 2025 TO ADD PUTTY BONEGRAFT.

  Patient problems: Fluid Discharge

  MAUDE report 23498490 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CERVICAL RADICULOPATHY DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: CASUAL RELATIONSHIP DATE OF EVENT: 3 SEP 2025 DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: (B)(6). TREATMENT/IMPACT: REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: YES, EXTENDING POSTERIOR FUSION DOWN TO T2 POSTERIORLY, MRI CONFIRMED ONGOING FORAMINAL STENOSIS WORSE AT (B)(6)

  Patient problems: Nerve Damage

  MAUDE report 23293915 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ACUTE THORACIC BACK PAIN BEGINNING ON (B)(6) 2021, AFTER INITIALLY HAVING A 4 TO 7 ANTERIOR CERVICAL DISCECTOMY AND FUSION. IMAGING SHOWED FAILURE OF HER DISTAL INSTRUMENTATION AND A FRACTURE OF THE C7 VERTEBRAL BODY. SHE UNDERWENT A DISTAL CORPECTOMY AND POSTERIOR CERVICAL FUSION ON (B)(6) 2021. SHE TOLERATED THE SURGERY WELL WITH NO COMPLICATIONS. SHE WAS DEEMED FIT FOR DISCHARGE ON (B)(6) 2021. HER PAIN WAS CONTROLLED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EIT CIF CAGE, H 6MM, 8°, S. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15739249 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ACUTE THORACIC BACK PAIN BEGINNING ON (B)(6) 2021, AFTER INITIALLY HAVING A 4 TO 7 ANTERIOR CERVICAL DISCECTOMY AND FUSION. IMAGING SHOWED FAILURE OF HER DISTAL INSTRUMENTATION AND A FRACTURE OF THE C7 VERTEBRAL BODY. SHE UNDERWENT A DISTAL CORPECTOMY AND POSTERIOR CERVICAL FUSION ON (B)(6) 2021. SHE TOLERATED THE SURGERY WELL WITH NO COMPLICATIONS. SHE WAS DEEMED FIT FOR DISCHARGE ON (B)(6) 2021. HER PAIN WAS CONTROLLED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EIT CIF CAGE, H 6MM, 8°, S. THIS IS REPORT 2 OF 2 FOR (B)(4)..

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15737731 ↗