INFINITY™ Occipitocervical Upper Thoracic System G3603512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169542235), received between Feb 23, 2025 and Feb 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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. 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.

• MalfunctionFeb 23, 2025Manufacturing, Packaging or Shipping Problem; Mechanics Altered; Manufacturing, Packaging or Shipping Problem; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN POSTERIOR CERVICAL FUSION THERAPY FOR CERVICAL DISLOCATION FRACTURE. IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INSTALL THE SCREW TO THE SCREWDRIVER, BUT THE SCREW HEAD WAS FIXATED AND COULD NOT BE MOVED, SO IT COULD NOT BE INSTALLED. IT WAS DETERMINED TO BE A DEFECTIVE PRODUCT, SO A NEW PRODUCT WAS OPENED AND IT WAS INSTALLED WITHOUT ANY PROBLEMS. THE OPERATION WAS COMPLETED SUCCESSFULLY. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS WERE REPORTED.IT WAS REPORTED THAT WHEN THE DEVICE WAS TAKEN OUT OF THE BOX AND ATTACHED TO THE SCREWDRIVER, THE ISSUE WAS NOTICED FOR THE FIRST TIME. IT WAS THE FIRST USE OF THE PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442479 ↗

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-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-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-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