BENGAL 187301206Recalls & reported problems
Depuy Spine, LLC · BENGAL SYSTEM LARGE IMPLANT 6mm, 7 DEGREES · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034137100), received between Jun 6, 2018 and Jun 6, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2018Break; Break
DR. (B)(6) WAS PERFORMING A C4-7 ANTERIOR CERVICAL FUSION WITH BENGAL CAGE AND SKYLINE ANTERIOR PLATE. AFTER DR.(B)(6) COMPLETED HIS DISCECTOMY AND DECOMPRESSION OF THE C4-5 DISC SPACE, HE PREPARED THE ENDPLATES AND INSERTED A 5MM LARGE FOOTPRINT TRIAL, FOLLOWED BY A 6MM LARGE FOOTPRINT TRIAL. HE DECIDED THE 6MM LARGE TRIAL WAS THE CORRECT FIT FOR THE DISC SPACE AND ASKED THE SURGICAL TECHNICIAN TO PREPARE A 6MM LARGE BENGAL IMPLANT ((B)(4)). ONCE LOADED ON THE BENGAL INSERTER ((B)(4)), DR.(B)(6) INSERTED THE GRAFT ((B)(4)) IN THE C4/5 DISC SPACE. DR.(B)(6) USED A SMALL MALLET TO ADVANCE THE GRAFT INTO THE PROPER POSITION. AFTER HE APPLIED FORCE WITH THE MALLET TO THE INSERTER APPROXIMATELY 4 TIMES, DR.(B)(6) NOTICED THAT DEEP GROOVES AND SURFACE CRACKS APPEARED ON THE ANTERIOR FACE OF THE IMPLANT. DR.(B)(6) REMOVED THE IMPLANT, INSPECTED THE DISC SPACE AND ENSURED IT WAS FREE OF IMPLANT FRAGMENTS, AND PROCEEDED TO INSERT A NEW CAGE ((B)(4)). THE SECOND CAGE WAS INSERTED INTO THE C4-5 DISC SPACE WITHOUT FURTHER INCIDENT. PATIENT CONSEQUENCE? : NO. ACTION TAKEN FOR PROCEDURE:DR.(B)(6) REMOVED THE DAMAGED IMPLANT. THE SURGICAL TECHNICIAN PREPARED A NEW IMPLANT ((B)(4)), ATTACHED THE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7572894 ↗
Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices
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- 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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