Navigated INFINITY™ Occipitocervical Upper Thoracic System NAVG3606010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169799936), received between Jul 6, 2020 and Dec 23, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065991 ↗
• InjuryJul 6, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L4-S1 SPINAL STENOSIS DUE TO TUMOR AT L4-S1 FOR SPINAL SURGERY. THE PROCEDURE PERFORMED WAS T2-S2 POSTERIOR SPINE FUSION. IT WAS REPORTED THAT THE SURGEON USED THE NAV INFINITY DRILL TO MAKE THE STARTING HOLES TO SET THE TRAJECTORY FOR THE SCREWS IN THE LUMBAR SPINE AND PELVIS. WHEN DRILLING FOR THE S2 ALAR ILIAC TRAJECTORY THE TIP OF THE DRILL (~30MM) BROKE OFF INSIDE THE PATIENT¿S PELVIS. THE DRILL BIT WAS USED WITHOUT THE DRILL GUIDE WHEN PLACING THE S2 SCREW. SURGEON THEN USED A SOLERA AWL TIP TAP TO CHANGE THE TRAJECTORY OF THE PILOT HOLE AWAY FROM THE FRAGMENT. A SOLERA 5.5 SCREW WAS PLACED SAFELY IN THE NEW TRAJECTORY, AWAY FROM THE BROKEN FRAGMENT. TOWARDS THE COMPLETION OF THE CASE AN O-ARM SPIN CONFIRMED THE LOCATION OF DRILL BIT FRAGMENT IN THE PATIENT¿S PELVIS. THE LEVELS IMPLANTED WAS L2-PELVIS. THERE WAS A FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF TH IS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10231508 ↗