NA 03.108.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982071712), received between Sep 26, 2019 and Feb 20, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN, IT WAS IDENTIFIED THAT ONE PART OF THE ALIGNMENT ROD WAS NOT THREADING. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422890 ↗
• MalfunctionMay 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, WHEN SETTING UP FOR A CASE, IT WAS DISCOVERED THAT THE ALIGNMENT ROD WAS BENT. NO LONGER USABLE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED ADDITIONAL ALIGNMENT RODS, IT WAS IDENTIFIED ON (B)(6) 2023 THAT RETURNED ADDITIONAL ALIGNMENT RODS ARE BENT. THIS REPORT IS FOR ONE (1) ALIGNMENT ROD. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16848131 ↗
• MalfunctionMay 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6)2023 , WHEN SETTING UP FOR A CASE, IT WAS DISCOVERED THAT THE ALIGNMENT ROD WAS BENT. NO LONGER USABLE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED ADDITIONAL ALIGNMENT RODS IT WAS IDENTIFIED ON (B)(6)2023 THAT RETURNED ADDITIONAL ALIGNMENT RODS ARE BENT. THIS REPORT IS FOR ONE (1) ALIGNMENT ROD. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16848092 ↗
• MalfunctionMar 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, WHEN SETTING UP FOR A CASE, IT WAS DISCOVERED THAT THE ALIGNMENT ROD WAS BENT. NO LONGER USABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ALIGNMENT ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587655 ↗
• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION WHILE RESTOCKING THE INSTRUMENT TRAY IT WAS OBSERVED THAT THE ALIGNMENT ROD APPEARS TO BE BENT. NO PATIENT INVOLVEMENT AND NO FURTHER INFORMATION AT THIS TIME. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ALIGNMENT ROD. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267751 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION OF A LOANER SET AN ALIGNMENT ROD WAS BROKEN. THERE WAS NO SURGICAL PROCEDURE OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ALIGNMENT ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9125648 ↗