BENGAL 177306130Recalls & reported problems
Depuy Spine, LLC · BENGAL STACKABLE CAGE SYSTEM STANDARD LORDOTIC 12 x 14 x 30mm, 0 DEGREES/6 DEGREES · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034060873), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2017Fracture; Off-Label Use
POST-OP IMAGING STUDIES DEMONSTRATE THAT THE BENGAL STACKABLE MONOLITH [(B)(4)] WAS SHOWN TO HAVE FRACTURED FOLLOWING IMPLANTATION INTO PATIENT'S NECK FOLLOWING C7 SINGLE-LEVEL ANTERIOR CERVICAL CORPECTOMY AND FUSION (ACCF). THE DEVICE CONSTRUCT CONSISTS OF MONOBLOCK LORDOTIC PROFILE WITH 12 X 14 MM FOOTPRINT AND 30 MM HEIGHT. IMAGING ALSO DEMONSTRATES THAT THE DEVICE PISTIONED INTO THE ADJACENT T1 VERTEBRA APPROXIMATELY 10 MM (GREATER THAN 3 MM WHICH IS CONSIDERED CLINICALLY SIGNIFICANT) RESULTING IN LOSS OF INTERVERTEBRAL SPACE COLLAPSE AND NEUROCOMPROMISE. THE DEVICE IS NOT APPROVED OR CLEARED FOR ANY INTENDED USES IN THE CERVICAL SPINE. THE DESIGN RATIONALE INCLUDING DIMENSIONS AND LORDOTIC PROFILE OF THE DEVICE ARE CONSISTENT WITH SPINAL IMPLANTS INTENDED FOR USE IN THE CERVICAL SPINE. THE 510(K) AND DEVICE LABELING, HOWEVER, REPRESENTS THAT THE DEVICE IS EXPLICITLY TO BE USED IN THE THORACOLUMBAR SPINE.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 6721432 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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