MESA® Small Stature Spinal System 3001-05535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857046733), received between Jul 31, 2020 and Jul 31, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE INNER COLLET OF 3 MESA SM STATURE DEFORMITY POLYAXIAL SCREWS BROKE DURING REDUCTION OF THE RAIL INTRA-OPERATIVELY. THE SCREWS WERE REMOVED AND REPLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE SECOND OF THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10353178 ↗
• MalfunctionJul 31, 2020Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THE INNER COLLET OF 3 MESA SM STATURE DEFORMITY POLYAXIAL SCREWS BROKE DURING REDUCTION OF THE RAIL INTRA-OPERATIVELY. THE SCREWS WERE REMOVED AND REPLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE FIRST OF THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10353173 ↗
• MalfunctionJul 31, 2020Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INNER COLLET OF 3 MESA SM STATURE DEFORMITY POLYAXIAL SCREWS BROKE DURING REDUCTION OF THE RAIL INTRA-OPERATIVELY. THE SCREWS WERE REMOVED AND REPLACED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT WILL REPRESENT THE THIRD OF THREE SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10353172 ↗