INFINITY™ Occipitocervical Upper Thoracic System G3603514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169542242), received between Aug 11, 2023 and Mar 12, 2025 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionMar 12, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C3-4 LMS, C6-7 PS POSTERIOR FIXATION (2A-2B) FOR C5 FRACTURE DUE TO FALL INJURY. IT WAS REPORTED THAT THE SCREW WAS PREPARED FOR LMS PLACEMENT, AND WHEN IT WAS TRIED TO PLACE IT ON A SCREWDRIVER, THE SCREW OF THE PRODUCT DID NOT FIT STRAIGHT INTO THE SCREWDRIVER. IT DID NOT FIT AND WAS PLACED ASKEW/IN A SLANTED ANGLE NO MATTER HOW MANY ATTEMPTS WERE MADE, SO IT WAS REPLACED WITH A PRODUCT OF THE SAME MODEL NUMBER AND SIZE.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581589 ↗
• 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 20167555 ↗
• InjuryAug 11, 2023Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR CERVI CAL FUSION FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT, LATERAL MASS OF VERTEBRAE WAS BROKEN WHILE IMPLANTING SCREW. THE STATUS OF THE SCREW WAS EXPLANTED-COMPLETE. TO IMPROVE POSTOPERATIVE SCREW FIXATION, THE 3.5MM SCREW WAS REMOVED AND REPLACED WITH A 4.5MM SCREW. THERE IS A POSSIBILITY THAT AN IMMENSE FORCE WAS EXERTED ON THE SCREW WHICH MAY CAUSE THE LATERAL MASS BROKEN. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17508305 ↗

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-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-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