FathomRecalls & reported problems across all models

We found 3 models of Fathom by Seaspine Orthopedics Corporation in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 22, 2024 and May 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fathom recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 17, 2024Class IIOpen, 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 · Recall details · FDA record ↗

2. May 17, 2024Class IIOpen, Classified

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

   Z-2234-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Fathom problems

Fathom models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fathom MR2-102050

  RETRACTOR
  1 recall1 report
• Fathom MR2-102035

  RETRACTOR
  1 recall0 reports
• Fathom MR2-102075

  RETRACTOR
  1 report

Recent Fathom adverse event reports

The 2 most recent reports across all models, 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 ↗
• 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 Seaspine Orthopedics Corporation products

• Mariner15 models · 147 reports · 1 recall
• Daytona Small Stature3 models · 14 reports · 2 recalls
• NorthStar24 models · 15 reports · 1 recall
• Meridian8 models · 8 reports · 1 recall
• Mariner Deformity3 models · 2 reports · 1 recall
• Mariner RDX6 models · 0 reports · 1 recall
• Virata25 models · 0 reports · 1 recall
• Reef TA2 models · 0 reports · 1 recall