MESA® Spinal System 801-06545Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888857136168), received between Sep 22, 2016 and Mar 9, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2022Migration; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO-MONTHS POST-OPERATIVELY THE MESA SCREWS AT RIGHT/LEFT L2 AND LEFT L3 MIGRATED. ALL THE RODS AND SCREWS WERE REMOVED AND REPLACED AND THE CONSTRUCT WAS EXTENDED. THIS REPORT CAPTURES THE SCREW AT LEFT L2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714792 ↗
• InjuryAug 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE "GROWING" BACK PAIN INTRA-OPERATIVELY. DURING REVISION, TWO MESA POLYAXIAL SCREWS WERE OBSERVED TO BE FRACTURED APPROXIMATELY 1CM BENEATH THE SCREW HEADS. THE SURGEON TRIED TO RETRIEVE THE SCREWS, BUT THEY WERE LEFT IN AS THE ONLY WAY TO RETRIEVE THE SCREWS WAS TO DRILL AWAY THE PEDICLE. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE SURGERY, WITH AN UNKNOWN DELAY, BY EXTENDING THE CONSTRUCT ONE LEVEL FURTHER DOWN. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: Pain

  MAUDE report 10451968 ↗
• InjuryAug 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE "GROWING" BACK PAIN INTRA-OPERATIVELY. DURING REVISION, TWO MESA POLYAXIAL SCREWS WERE OBSERVED TO BE FRACTURED APPROXIMATELY 1 CM BENEATH THE SCREW HEADS. THE SURGEON TRIED TO RETRIEVE THE SCREWS, BUT THEY WERE LEFT IN AS THE ONLY WAY TO RETRIEVE THE SCREWS WAS TO DRILL AWAY THE PEDICLE. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE SURGERY, WITH AN UNKNOWN DELAY, BY EXTENDING THE CONSTRUCT ONE LEVEL FURTHER DOWN. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: Pain

  MAUDE report 10451966 ↗
• InjuryApr 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. THE PATIENT WAS REVISED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: Injury

  MAUDE report 9960628 ↗
• InjuryApr 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. THE PATIENT WAS REVISED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: Injury

  MAUDE report 9960467 ↗
• MalfunctionMay 26, 2017Fracture; Fracture

  ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH SCREW FRACTURES. THE PATIENT REPORTEDLY HAD SCREW FRACTURES APPROXIMATELY 12 MONTHS POST-OP. THE PATIENT HAS NOT BEEN REVISED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6595523 ↗
• MalfunctionSep 22, 2016Break; Break

  ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SCREW FRACTURED. THE PATIENT REPORTEDLY HAD A FRACTURED SCREW APPROXIMATELY 12 MONTHS POST-OP.

  Patient problems: Pain

  MAUDE report 5969444 ↗