n/a 6550014Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169754560), received between Aug 19, 2025 and Feb 9, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD GRIPPERS WOULD NOT GRIP ONTO RODS. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE ROD GRIPPERS WILL NOT TIGHTEN DOWN ON ROD EVEN AFTER ADJUSTING THE TENSION. THE REPORTED DEVICES WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289200 ↗
• MalfunctionFeb 9, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE ROD GRIPPERS WOULD NOT GRIP ONTO RODS. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE ROD GRIPPERS WILL NOT TIGHTEN DOWN ON ROD EVEN AFTER ADJUSTING THE TENSION. THE REPORTED DEVICES WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289193 ↗
• MalfunctionAug 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT THE ROD GRIPPER, WAS UNABLE TO HOLD THE ROD DUE TO A BROKEN INTERNAL TENSION MECHANISM. ADDITIONALLY, THE INSERTER WAS MISSING AN INTERNAL ENGAGEMENT SLEEVE. THE REDUCERS FAILED TO HOLD ONTO THE SCREW BECAUSE THE FOUR PRONGS THAT ENGAGE THE SCREW APPEARED TO BE WORN DOWN. FURTHERMORE, THE TIP OF THE SCREWDRIVER WAS BROKEN AT THE INTERFACE WITH THE SCREW. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837597 ↗