ENDOSKELETON® TAS 2300-1312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191375025795), received between Dec 22, 2021 and Mar 10, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE DOES NOT SPIN/MOVE UP AND DOWN AS IT SHOULD. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556225 ↗
• MalfunctionAug 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR NON UNION OF SCOLIOSIS CORRECTION AT L3-S1. PROCEDURE OR TECHNIQUE USED WAS ALIF. LEVELS IMPLANTED L3-S1. IT WAS REPORTED THAT DURING THE CAGE INSERTION STEP, THE INSERTER BOUND UP AND WOULD NOT WORK. INSERT WAS BROKEN, THE TIP DOESN¿T ROTATE. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202380 ↗
• MalfunctionJun 27, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR NON UNION LUMBAR L3-S1. LEVELS IMPLANTED L3-S1. PROCEDURE OR THERAPY PERFORMED WAS ALIF. IT WAS REPORTED THAT THE INSERTER FROZE DURING INSERTION OF THE CAGE AND WILL NOT MOVE FORWARD OR BACKWARD WHEN TRYING TO SPIN THE INNER SHAFT. INSERTER WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14825567 ↗
• MalfunctionDec 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY AT L4-S1 FOR SCOLIOSIS. IT WAS REPORTED THAT THE TIP OF THE INSERTER BOUND UP AND WOULD NOT ROTATE CAUSING THE INSERTER TO NOT WORK CORRECTLY. SURGEON COULD NOT TWIST THE T HANDLE AND MAKE THE INSERTER MOVE AT ALL. THE TIP WAS BROKEN. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058232 ↗