INFINITY™ Occipitocervical Upper Thoracic System G3602550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169549616), received between Feb 12, 2025 and Mar 26, 2025 — classified as 2 injuries.

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

• InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED: PER SURGEON'S PROCEDURE NOTE, THERE WAS A SMALL AMOUNT OF DARK STAINING ADJACENT TO THE T10 ROD CONNECTORS SUGGESTIVE OF METALLOSIS WHICH WOULD BE CONSISTENT WITH MECHANICAL LOOSENING. THERE WAS NO OBVIOUS METALLOSIS AT THE T5-T7 REGIONS WHERE THE ACCESSORY RODS WERE LOCATED. AT THE CERVICO THORACIC JUNCTION ONE OF THE RIGHT SIDED CERVICAL-THORACIC RODS WAS NOT GROSSLY LOOSE BUT WITH GRASPING IT WITH HEAVY NEEDLE DRIVER COULD ROTATE THE CONNECTOR WHICH ALSO DEMONSTRATED MECHANICAL LOOSENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695445 ↗
• InjuryFeb 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (B)(6). IT WAS REPORTED THAT THERE WAS A HARDWARE FAILURE OF THE ANTERIOR COLUMN OF THE SPINE INVOLVING A ROD CONNECTOR. AN INCISION WAS MADE ING INSTRUMENTATION FROM T1 DOWN TO T9, AND THE SIDE-TO-SIDE DOMINO CONNECTORS AT T2-3 WERE FOUND TO BE GROSSLY LOOSE. THE PATIENT REPORTED DISCOMFORT, AND THE EXISTING HOSPITALIZATION WAS PROLONGED. ADDITIONAL SURGERY WAS REQUIRED, DURING WHICH SET CAPS, CONNECTORS, AND RODS FROM T3 DOWN TO THE T9 AXIAL CONNECTOR WERE REMOVED, AS WELL AS PEDICLE SCREWS FROM T3, T4 BILATERALLY, T7 ON THE RIGHT, AND T8 ON THE LEFT. CULTURES WERE SENT FROM THE RIGHT T4 PEDICLE SCREW TRACT. PHYSICAL THERAPY WAS ADMINISTERED AS A TREATMENT. THE OUTCOME OF THIS ADVERSE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE ADVERSE EVENT (AE) WAS FIRST DETERMINED TO BE A SERIOUS ADVERSE EVENT (SAE) ON (B)(6) 2025. THE HOSPITALIZATION STARTED ON (B)(6) 2025. INVESTIGATOR ASSESSMENT: THE ADVERSE EVENT (AE) IS RELATED TO A STUDY PROCEDURE AND HAS A CAUSAL RELATIONSHIP WITH THE PROCEDURE, IDENTIFIED AS "ADDITIONAL SURGERY." ADD

  Patient problems: Discomfort

  MAUDE report 21362709 ↗

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-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-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-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