INFINITY™ Occipitocervical Upper Thoracic System 3604522Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169541801), received between Jul 2, 2026 and Jul 2, 2026 — classified as 1 malfunction.

5 other recalls cover devices cleared under the same FDA submission (K163375); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026No Apparent Adverse Event

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE ROD AND SET SCREW WAS LOOSENED AT T1 LEVEL POST-OPERATIVELY. PATIENT EXPERIENCED NECK PAIN, AND COULD HEAR SQUEAKING WHEN MOVING NECK. SQUEAKING SENSATION UP TO HER SKULL. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED STATING PROCEDURE PERFORMED WAS C4 - T1 POSTERIOR EXTENSION OF FUSION. MAS WERE INTACT, NO FAILURE ASSOCIATED WITH MAS SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688650 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163375. One submission often covers many models, so check the product and lot details in each record.

• Z-1412-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1409-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1411-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as
• Z-1410-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion
• Z-1413-2023 · Feb 16, 2023 · Open, Classified
  INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion