SPINE REFERENCE CLAMP (CARBON) 55758Recalls & reported problems
Brainlab SE · Class 2
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 04056481139278), received between Dec 12, 2025 and Dec 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
A MINIMALLY INVASIVE SURGERY ON THE LUMBAR SPINE DUE TO A SPINAL STENOSIS AT L4/L5 WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE SPINE & TRAUMA NAVIGATION 2.0. AFTER THE SURGERY, DAMAGE TO THE SPINE REFERENCE CLAMP (CARBON) WAS DISCOVERED, WHICH LED TO AN ADDITIONAL SURGERY, ON THE SAME DAY, TO REMOVE PIECES OF THE DAMAGED CLAMP THAT HAD BEEN LEFT IN THE PATIENT. ACCORDING TO THE SURGEON: AN ADDITIONAL SURGERY WAS PERFORMED DUE TO THE REPORTED PROBLEM. ALL PARTS OF THE DAMAGED SPINE REFERENCE CLAMP (CARBON) THAT HAD BEEN LEFT IN THE PATIENT'S BODY WERE REMOVED DURING THE ADDITIONAL SURGERY. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.
Patient problems: Foreign Body In Patient
MAUDE report 23789471 ↗
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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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