Navigated Infinity ™ Instruments NAV3606030Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169725423), received between Dec 23, 2020 and Mar 13, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVICAL PROCEDURE. IT WAS REPORTED THAT, TAP WAS BROKEN IN HALF DURING USE. TIP HAD TO BE RECOVERED FROM PATIENT BONE. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596771 ↗
• MalfunctionDec 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT TAP BROKE OFF IN PEDICLE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717458 ↗
• MalfunctionNov 12, 2025Break; Product Quality Problem; Break; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A TAP USED ON PATIENT HAVING C2-T2 CERVICAL MYELOPATHY THERAPY. IT WAS REPORTED THAT THE TIP OF THE TAP BROKE OFF INSIDE THE BONE AND THE TIP WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED BY USING A 3.0 TAP. THE TIP COULD NOT BE RETRIEVED AND HAD TO STAY IN THE PATIENT, BUT IT IS IN C2 ON THE RIGHT SIDE. THIS WAS A BRAND NEW 2.4 DRILL BIT OUT OF THE BOX AND HAD BEEN USED FOR MAYBE 20 MINUTES PRIOR TO THIS HAPPENING. THERE WAS NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23533406 ↗
• MalfunctionJul 1, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE TAP DEVICE BROKE OFF WHILE TRYING TO REVERSE THE TAP FROM THE RIGHT C1 BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369187 ↗
• MalfunctionJun 11, 2025Crack; Crack

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE TIP OF THE TAP WAS CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181984 ↗
• MalfunctionMay 29, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TAP BROKE OFF IN THE PATIENT HALFWAY UP THE THREADS. WE WERE ABLE TO RETRIEVE THE BROKEN PIECE OUT OF THE PATIENT BUT ATTEMPTED TO TAP SLIGHTLY PAST WHAT WE DRILLED TO. THERE WAS A DELAY OF ABOUT 30 MINUTES IN THE OVERALL PROCEDURE TIME, IN ORDER TO GET THE BROKEN TAP TIP OUT OF THE PATIENT BY THE HCP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103726 ↗
• InjuryAug 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE POSTERIOR CERVICAL FUSION FOR ATLANTOAXIAL SUBLUXATION. IT WAS REPORTE THAT THE TIP OF THE TAP REMAINED IN THE POSTERIOR ARCH AND VERTEBRAL BODY, SO BONE THAT DID NOT NEED TO BE REMOVED WAS REMOVED, AND THERE WAS A CHANGE IN THE FIXATION PROCEDURE. THE CHANGE IN PROCEDURE RESULTED IN AN INCREASE IN BLOOD LOSS OF ABOUT 100 CC AND PROLONGED THE OPERATION TIME BY MORE THAN ONE HOUR, INCLUDING THE TIME FOR HEMOSTASIS.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 20033489 ↗
• InjuryDec 23, 2020Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH C1, C2 FRACTURE FOR FUSION. IT WAS REPORTED THAT THE SPINOUS PROCESS CLAMP WAS NOT STABLE WHEN CLAMPED ON THE C2 SPINOUS PROCESS DUE TO THE DRILL BIT THE TAP NOT ADVANCING IN THE BONE. THE PHYSICIAN HAD TO PUSH HARD TO GET THEM TO ENGAGE AND THEREFORE THE ANATOMY SHIFTED. THE AMOUNT OF FORCE APPLIED TO GET THE TAP TO ENGAGE WAS WHAT LED TO THE MISALIGNMENT AND LOSS OF FIDELITY. A C2 SCREW WAS PLACED DIRECTLY IN THE VERTEBRAL ARTERY AND THE PATIENT WAS TAKEN TO IR AFTER SURGERY TO CONFIRM NO FURTHER ACTION WAS NEEDED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENTS WERE DULL AND HARD TO ADVANCE. PHYSICIAN FELT THE NAV 2.4 DRILL BITS (BRAND NEW) AND OUR TAPS WERE DULL. THERE WAS A 1 HOUR DELAY IN PROCEDURE DUE TO RE-SPINNING AND TRYING TO SEAT THE ROD WITH THE MISPLACED SCREW AT C2 ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE EVENT IS AN OUT OF BOX FAILURE AS PER PHYSICIAN. THE GENERAL OBSERVATION OF THE PHYSICIAN ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066048 ↗