NuVasive 6006618Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887517273437), received between Nov 19, 2023 and Mar 25, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688744 ↗
• MalfunctionSep 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218382 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820524 ↗
• MalfunctionFeb 23, 2024Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE INSERTER FRACTURED OFF INTO THE TRIAL DURING INSERTION INTO L2/3. THE BROKEN PIECE WAS EMBEDDED IN THE TRIAL; THE ENTIRE TRIAL WAS REMOVED FROM THE DISC SPACE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773368 ↗
• MalfunctionFeb 14, 2024Fracture; Fracture

  ON (B)(6) 2024 AN EXTREME LATERAL INTERBODY FUSION WAS PERFORMED ON L1/3 AND POSTERIOR FIXATION WAS PERFORMED ON L1/S. DURING THE INSERTION OF THE TRIAL INTO L2/3, THE CONNECTION BETWEEN THE TRIAL AND THE INSERTER WAS BROKEN. THE DAMAGED FRAGMENT WAS REMOVED FROM THE INTERVERTEBRAL SPACE WITH THE ENTIRE TRIAL. AN ANGLED TYPE OF INSERTER WAS USED INSTEAD. NO ADDITIONAL ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707705 ↗
• MalfunctionDec 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275930 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TRIAL INSERTER TIP FRACTURED OFF INSIDE THE TRIAL AS THE TRIAL WAS BEING REMOVED FROM THE L3/4 DISC SPACE. THE FRACTURED PORTION WAS RETRIEVED ALONG WITH THE TRIAL AND NO FRAGMENT WAS LEFT IN-SITU. ANOTHER INSERTER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243326 ↗
• MalfunctionNov 19, 2023Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE INSERTER FRACTURED OFF IN THE TRIAL DURING INSERTION INTO L3/4, AND THE BROKEN PIECE WAS LODGED IN THE TRIAL. THE TRIAL WAS THEN REMOVED FROM THE INTERVERTEBRAL SPACE AND NO BROKEN FRAGMENT WAS LEFT IN-SITU. THE PATIENT'S INTERVERTEBRAL SPACE WAS REPORTED TO BE NARROW. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167319 ↗