ELEVATE™ Spinal System NAV2132 (UDI 00763000880385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000880385), received between Nov 21, 2024 and Jan 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Break; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS R EPORTED THAT THE INSERTER TIP WAS BENT. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE HANDLE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973757 ↗
• MalfunctionJan 5, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT INSERTERS WERE BROKEN AS HANDLES BROKE ON BOTH. 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 23960340 ↗
• MalfunctionNov 26, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDLE AND INSERTER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE HANDLE WOULD NOT RATCHET AND NOT FUNCTIONAL AND THE TIP OF THE INSERTER WAS BENT. THERE WAS NO PATIENT INVOLVEMENT AND EVENT WAS FOUND BEFORE SURGERY STARTED. PRODUCT HAD BEEN USED NUMEROUS TIMES PRIOR TO THIS CASE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654340 ↗
• MalfunctionNov 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT HANDLE BROKE OFF. 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 23568895 ↗
• MalfunctionFeb 7, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332033 ↗
• MalfunctionNov 21, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. 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 20742732 ↗