N/A 6956164Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074511429), received between May 6, 2024 and Mar 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR CERVICAL FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE ROD HOLD PART WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531617 ↗
• MalfunctionMar 6, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR POSTERIOR CERVICAL FIXATION SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE SPRING WAS BROKEN AND IS UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529978 ↗
• MalfunctionAug 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE ROD HOLDER BROKE IN HALF. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE REPORTED DEVICE WAS AN INSTRUMENT OUT OF THE CENTERPIECE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791990 ↗
• MalfunctionSep 3, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE OPEN/CLOSE MECHANISM WAS NOT WORKING PROPERLY DURING SET ASSEMBLY. 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 20124760 ↗
• MalfunctionMay 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, LEAF SPRING WAS BROKEN AND IT CANNOT HOLD THE IMPLANT. NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256435 ↗