BENGAL 187301105Recalls & reported problems
Depuy Spine, LLC · BENGAL SYSTEM STANDARD IMPLANT 5mm, 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034136967), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (C6-C7) SURGERY. POST-SURGERY, THE PATIENT HAS DEVELOPED SOME SKIN CONDITION AND IS CURRENTLY UNDERGOING EXTENDED SKIN PATCH TESTING TO RULE OUT IF THE PATIENT IS NOT ALLERGIC TO ANY OF THE METALS THAT WERE PLACED INTO THE PATIENT'S NECK. THE SURGEON AND DERMATOLOGIST PERFORMED EXTENDED PATCH TESTING AND VANADIUM CHLORIDE CAME BACK POSITIVE OUT OF 80 COMMON PATCHES AFTER 48 HOURS AFTER SURGERY. MONITORING WITH ALLERGISTS AND DERMATOLOGISTS, WORKING TOGETHER TO POTENTIALLY PRESCRIBE MEDICATIONS. THE SURGEON WILL DISCUSS WHETHER OR NOT A REVISION WILL BE NECESSARY AFTER FUSION. THE PATIENT WAS IMPLANTED WITH A PLATE FROM DEPUY SPINE, ONE SCREW IS FROM DEPUY SYNTHES AND ANOTHER ONE SCREW IS FROM JOHNSON HEALTH AND A CAGE FROM DEPUY SPINE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS 1 OF 6 FOR (B)(4).
Patient problems: Skin Irritation
MAUDE report 9728849 ↗
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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