INFINITY™ Occipitocervical Upper Thoracic System G360T0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169556539), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 malfunction.

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

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.

• MalfunctionApr 22, 2026Break

  INFORMATION WAS OBTAINED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW BEING USED FOR POSTERIOR SPINAL FIXATION (INCLUDING THE OCCIPITAL BONE) IN A PATIENT WITH THE PRE-OPERATIVE DIAGNOSIS OF AXIAL FRACTURE. THE SCREW WAS BEING IMPLANTED IN THE OCCIPITAL BONE BUT WHEN THE SCREW TIP WAS SLIGHTLY INSERTED INTO THE PATIENT AND THEN WITHDRAWN ONCE, DEFORMATION OR CHIPPING OF THE SCREW WAS OBSERVED. PATIENT INVOLVED DID NOT EXPERIENCE ANY SYMPTOMS AS A CONSEQUENCE OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PROCEDURE INVOLVED IN THE EVENT WAS POSTERIOR CERVICAL FIXATION INCLUDING THE OCCIPITAL BONE. THE EVENT OCCURRED DURING FIXATION WITH SCREWS FOR THE OCCIPITAL PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951881 ↗

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-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
• 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