Fathom MR2-102075Recalls & reported problems
Seaspine Orthopedics Corporation · C/C Blade, 75-115mm · Class 1
- 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 10889981300074), received between May 22, 2024 and May 22, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY UTILIZING SEASPINE'S FATHOM PEDICLE-BASED RETRACTOR COMPOSED OF MR2-102075 C/C BLADE, 75-115MM AND MR2-102050 C/C BLADE, 50-80MM. THE SUPERIOR C/C BLADE BROKE DURING USE, CAUSING A NUT TO FALL INTO THE SURGICAL SITE TWICE. THE NUT WAS RETRIEVED WITHOUT COMPLICATION. THIS RESULTED IN A 45 MIN SURGICAL DELAY. NO ADDITIONAL ANESTHESIA WAS REQUIRED, SURGERY WAS COMPLETED WITHIN NORMAL SURGICAL TIMEFRAME. SEASPINE WAS MADE AWARE OF THE DELAY ON (B)(6) 2024. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT IS FOR THE MR2-102075 C/C BLADE, 75-115MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19378100 ↗
Other RETRACTOR devices
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- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 10269Integra Lifesciences Corporation · RETRACTOR1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.