INFINITY™ Occipitocervical Upper Thoracic System G3603528Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169542310), received between Mar 20, 2025 and Mar 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• MalfunctionMar 20, 2025Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING POSTERIOR CERVICAL FUSION AT LEVELS C1-3 FOR C1, C2 FRACTURE. IT WAS REPORTED THAT THE 28MM RIGHT C1 SCREW WAS SHORTER AND WAS NOT TOUCHING THE TIP OF THE SCREW IN THE FRACTURE LINE WHEN INSERTING, SO IT WAS CHANGED TO 30 MM. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650419 ↗

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-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-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-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