BRECKENRIDGE INTERVERTEBRAL BODY/VBR FUSION SYSTEM 8880-5214Recalls & reported problems
Biomet Spine LLC · Class 2 · Implant
Data updated Oct 18, 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 00888480572886), received between Oct 21, 2020 and Oct 21, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.
Most reported problems
Device problems
- Biocompatibility1
Patient problems
- Eczema1
- Hypersensitivity/Allergic reaction1
- Rash1
- Swelling1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2020Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE AN EPIC CONSTRUCT AND A BRECKENRIDGE CAGE. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT SIX OF SEVEN FOR THIS EVENT.
Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema
MAUDE report 10713122 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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