INFINITY™ Occipitocervical Upper Thoracic System G3603524Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169542297), received between Sep 9, 2024 and Jul 2, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 2, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR CERVICAL FRACTURE. IT WAS REPORTED THAT DURING A C2-C7 SPINAL FIXATION PROCEDURE, A POTENTIAL MISALIGNMENT OF THE NAVIGATION SYSTEM (O-ARM) RESULTED IN THE LEFT PEDICLE SCREW AT C4 BEING MISPLACED BY 5 MM OR MORE, POSING A RISK OF VERTEBRAL ARTERY (VA) DAMAGE. DUE TO THE HIGH RISK OF HEMORRHAGING IF REPOSITIONED, THE SURGICAL TEAM DECIDED TO LEAVE THE SCREW IN PLACE AND PROCEEDED WITH WOUND CLOSURE. POST-OPERATIVELY, THE PATIENT DID NOT REGAIN CONSCIOUSNESS AND WAS TRANSFERRED TO THE WARD. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Loss of consciousness

  MAUDE report 22381682 ↗
• InjurySep 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCTS. IT WAS REPORTED THAT, THERE WAS LOOSENING OF THE RIGHT C6 LATERAL MASS SCREW (LMS) AND C7 PEDICLE SCREW (PS) AFTER THE INITIAL OPERATION. REVISION SURGERY WAS PERFORMED TO EXPLANT THE RIGHT C6 LMS AND C7 PEDICLE SCREW. DURING THE REVISION, C6 BILATERAL PEDICLE SCREWS WERE IMPLANTED, AND RIGHT C7 PEDICLE SCREW WAS SIZED UP. (F3.5/24 HAS BEEN CHANGED TO F4.5/26). PROCEDURE OR TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS META C6-TH4 FIXATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167594 ↗

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-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-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-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