ENDOSKELETON® TAS 2300-1110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191375001942), received between Jun 6, 2024 and Jun 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR LUMBAR INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT AN AWL FIXED HANDLE STRAIGHT SOLID INSTRUMENT BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662356 ↗
• MalfunctionMar 17, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE AWL HANDLE WAS BROKEN AND THE DRIVER WAS STRIPPED. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE MANY TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619679 ↗
• MalfunctionSep 3, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT AWL TIP WAS BENT <(>&<)> BROKE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949695 ↗
• MalfunctionJan 9, 2025Break; Break

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113294 ↗
• MalfunctionJan 4, 2025Break; Naturally Worn; Break; Naturally Worn

  INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE WORN AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074940 ↗
• MalfunctionDec 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF AWL WAS BENT, BROKE OFF. CURETTE WAS BENT. ALSO, INSTRUMENT DOES NOT CUT & DULL. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034281 ↗
• MalfunctionJun 6, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE VIA A HEALTHCARE PROFESSIONAL REGARDING A FIXED ANGLE AWL HAVING L4-S1 A NTERIOR LUMBAR INTERBODY FUSION (ALIF) THERAPY. IT WAS REPORTED THAT STRAIGHT AWL WAS BROKEN AND BENT DURING THE ALIF WHILE TRYING TO PUT AN IMPLANT IN DURING A PROCEDURE. PATIENT SYMPTOMS WERE UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19474390 ↗