MESA Spinal System 801-90143Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857143654), received between Jan 2, 2020 and Mar 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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.

• MalfunctionMar 24, 2022Material Deformation; Material Deformation

  A COMPANY REPRESENTATIVE REPORTED THAT A MESA RAIL/ROD PULLER BECAME DEFORMED DURING A SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895942 ↗
• MalfunctionJul 29, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A MESA RAIL/ROD PULLER WAS DISCOVERED TO BE BENT PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO ADVERSE CONSEQUENCES WERE SEEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341516 ↗
• InjuryJan 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A MESA ROD PULLER TIP DEFORMED INTRA-OPERATIVELY WHILE ATTEMPTING TO UNLOCK A 4TH SCREW AFTER SUCCESSFULLY UNLOCKING 3 SCREWS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9539494 ↗