INFINITY™ Occipitocervical Upper Thoracic System G3602536Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169549470), received between Sep 19, 2024 and Sep 19, 2024 — 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS ATLANTOAXIAL SUBLUXATION AT C23. IT WAS REPORTED THAT THE ROD CROSS-LINK M WAS BROKEN AT CONNECTING AREA AT THE MIDLINE CONNECTION. AFTER IT WAS DAMAGED, THE SIZE WAS CHANGED AND THE DEVICE WAS INSTALLED. 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 20255252 ↗

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-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
• 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