EIT CIF cage CUI8070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260557770573), received between Oct 15, 2025 and Nov 13, 2025 — classified as 4 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 20, 2022Open, Classified

   Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton

   Z-1324-2022 · Root cause: Labeling Change Control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: THERE WAS REOPERATION/SURGICAL INTERVENTION (POSTERIOR INSTRUMENTATION) DATED ON (B)(6) 2025 FOR THE ADDITIONAL DEVICE IMPLANTED NOT DEPUY DEVICES FOR THE TREATMENT OF C3-C4, C4-C5, C5-C6, C6-C7, C7-T1 AND T1-T2 LEVELS. NOT DEPUY DEVICES ADDED: POSTERIOR RODS AND POSTERIOR SCREWS. MAGNETOS PUTTY BONEGRAFT.

  Patient problems: Fluid Discharge

  MAUDE report 23541473 ↗
• 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)(6). CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DRAINAGE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: PROBABLE DATE OF EVENT: (B)(6) 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: YES DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: CUI8060S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: EIT CIF CAGE, H 6MM, 8°, S CATALOG NUMBER: UNK - SCREW LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: SCREW BONE 16MM 3.5MM SELF DRILL VARIABLE ANGLE CATALOG NUMBER: UNK - RODS LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: NO INFORMATION PROVIDED CATALOG NUMBER: CUI8070S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: EIT CIF CAGE, H 7MM, 8°, S CATALOG NUMBER: UNK - SCREW LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: SCREW BONE 16MM 3.5MM SELF DRILL VARIABLE ANGLE 102250016 CATALOG NUMBER: UNK - RODS LOT NUMBER: NO

  Patient problems: Fluid Discharge

  MAUDE report 23498586 ↗
• 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: YES DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: CUI8060S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: EIT CIF CAGE, H 6MM, 8°, S CATALOG NUMBER: UNK - SCREW LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: SCREW BONE 16MM 3.5MM SELF DRILL VARIABLE ANGLE CATALOG NUMBER: UNK - RODS LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: NO INFORMATION PROVIDED CATALOG NUMBER: CUI8070S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: EIT CIF CAGE, H 7MM, 8°, S CATALOG NUMBER: UNK - SCREW LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: NO INFORMATION PROVIDED DESCRIPTION: SCREW BONE 16MM 3.5MM SELF DRILL VARIABLE ANGLE (B)(6) CATALOG NUMBER: UNK - RODS LOT NUMBER: NO INFO

  Patient problems: Fluid Discharge

  MAUDE report 23498503 ↗
• 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: C3-C4, C4-C5, C5-C6, C6-C7. 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 C4-5 AND C5-6.

  Patient problems: Nerve Damage

  MAUDE report 23294040 ↗