INFINITY™ Occipitocervical Upper Thoracic System 3603514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169554405), received between Oct 9, 2020 and Aug 25, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST C3-C6 POSTERIOR CERVICAL FIXATION PROCEDURE WITH DECOMPRESSION IN A PATIENT WITH MEDICAL HISTORY OF NECK PAIN AND DIFFICULTY IN WALKING AND INABILITY TO HOLD ANYTHING WELL WITH HIS ARM. IT WAS REPORTED THAT 2 MONTH AFTER SURGERY, PATIENT VISITED THE CLINIC WITH WEAKNESS IN HIS ARM. PATIENT HAD MORE WEAKNESS IN HIS HAND AND SURGEON EXPECT THIS FROM BROKEN SCREW. PATIENT DID NOT ACHIEVE FUSION 2 MONTH POST SURGERY. NO PLAN TO EXPLANT THE SCREW. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle Weakness/Atrophy

  MAUDE report 22881849 ↗
• InjuryApr 27, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERV ICAL REVISION FOR FUSION FAILURE. IT WAS REPORTED THAT WHILE DOING A POSTERIOR CERVICAL REVISION, TOOK THE SET SCREWS AND ROD OUT OF THE LEFT C4-6 CONSTRUCT AND WENT TO USE THE HEAD TURNER ON THE C6 SCREW AND REALIZED THE ENTIRE SCREW WAS IN PIECES. PRODUCT WILL BE RETURNED. THERE WERE NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE  REASON FOR THIS REVISION SURGERY WAS FUSION FAILURE.

  Patient problems: Spinal Column Injury

  MAUDE report 16821844 ↗
• MalfunctionOct 9, 2020Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVICAL FUSION DUE TO CERVICAL MYELOPATHY. IT WAS REPORTED THAT SCREW NOT TAPPING WHEN INSERTED INTO PRE-DRILLED HOLE. THERE WERE NO SYMPTOMS REPORTED. THE PRODUCT WAS REPLACED AND WILL BE RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10654894 ↗

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-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-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