Fathom MR2-102050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889981300067), received between May 22, 2024 and May 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 17, 2024Open, Classified

   Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

   Z-2235-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

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 6 MAY 2024. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT IS FOR THE MR2-102050 C/C BLADE, 50-80MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378114 ↗