INFINITY™ Occipitocervical Upper Thoracic System 3602536Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169527676), received between Sep 16, 2020 and Feb 23, 2025 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2025Break; Defective Component; Mechanical Jam; Break; Defective Component; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING THE DEVICES USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE FEMALE MECHANISM USED TO ENGAGE THE T10 DRIVER TO LOCK THE IMPLANT HEIGHT IS STRIPPED. THE TIP OF THE DRIVER IS CRACKED. THE MIDDLE SET SCREW OF CROSSLINK AS ARRIVED IN PACKAGING WAS STUCK, IT WOULD NOT LOOSEN OR TIGHTEN AND UPON TRYING TO LOOSEN THE IMPLANT BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442387 ↗
• MalfunctionSep 16, 2020Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH TRAUMA. IT WAS REPORTED THAT THE LATERAL SET SCREW STRIPPED AS SURGEON WAS ATTEMPTING TO FINAL TIGHTEN. THE DEVICE WAS REPLACED, AND WILL BE RETURNED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ON (B)(6) 2020, (REP) ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH OCCIPUT TO C4 P OSTERIOR FUSION (LEVELS IMPLANTED-OCCIPUT TO C4) DUE TO TRAUMA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10539976 ↗

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-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-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