INFINITY™ Occipitocervical Upper Thoracic System 3600600Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169527423), received between Jan 11, 2021 and Jan 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJan 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. EVENT OCCURRED DURING USE OF THE DEVICE. IT WAS REPORTED THAT PATIENT HAD NEW CERVICAL OCCIPITAL PAIN, ONE MONTH POST OP. ADMITTED THROUGH ER. IMAGING SHOWED THE PLATE AND SCREWS HAD PULLED OUT OF THE BONE. DEVICE EXPLANT WAS PLANNED FOR (B)(6) 2020. NO FURTHER PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE WILL BE RETURNED POST EXPLANT. UPDATE; THE EXPLANT OF THE DEVICES WAS COMPLETED ON (B)(6) 2020. THE PROCEDURE WAS TO EXPLANT THE OC PLATE, OCCIPITAL BONE SCREWS, RODS AND SET SCREWS (PRIMARY SURGERY WAS OCCIPUT PLATE, TO C3-C5 LATERAL MASS SCREWS). C1 SCREWS WERE IMPLANTED, C6 LATERAL MASS SCREWS IMPLANTED, T1 AND T2 PEDICLE SCREWS WERE IMPLANTED, NEW RODS AND SET SCREWS WERE IMPLANTED. PATIENT IS NOW RECOVERING AND WEARING A COLLAR.

  Patient problems: Neck Pain

  MAUDE report 11145037 ↗

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-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-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