CALIBER 594.426Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849044021028), received between Feb 25, 2022 and Jul 7, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 7, 2022Device Dislodged or Dislocated; Material Deformation; Appropriate Device Problem Term/Code Not Available

  PATIENT UNDERWENT L3-4 AND L4-5 TRANSFORAMINAL LUMBAR INTERBODY ARTHRODESIS WITH POSTERIOR LATERAL FUSION AND INSTRUMENTATION. POST OPERATIVE IMAGING DEMONSTRATED HARDWARE IN GOOD PLACEMENT. 3 WEEKS POST FUSION, PATIENT DEVELOPED ACUTE ONSET OF LEFT LOWER EXTREMITY RADICULAR PAIN THAT STARTED APPROXIMATELY 3 WEEKS AGO. HIS IMAGING STUDIES SHOW EVIDENCE OF POSTERIOR DISPLACEMENT OF THE L4-5 INTERBODY CAGE AND RECURRENT SPONDYLOLISTHESIS AT THE L4-5 LEVEL. GIVEN THE FINDINGS ON THE IMAGING STUDIES AND THE PATIENT'S NEUROLOGICAL SYMPTOMS, THE PLAN IS TO PERFORM REMOVAL OF THE L4-5 INTERBODY CAGE, DECOMPRESSION OF THE LATERAL RECESS AND SPINAL CANAL AND REVISION OF THE INTERBODY ARTHRODESIS AND PLACEMENT OF THE INTERBODY CAGE. ON REVISION -THE SCREW WAS TURNED IN A COUNTER- CLOCKWISE DIRECTION ALLOWING FOR COLLAPSE OF THE CAGE. THIS PROVIDED ONLY FOR COLLAPSE OF THE CAUDAL PORTION OF THE L4-5 INTERBODY CAGE. THE ROSTRAL PORTION OF THE CAGE DID NOT COLLAPSE AND COULD BE SEEN TO BE RELATIVELY DEFORMED RELATIVE TO THE TITANIUM CORE.

  Patient problems: Pain

  MAUDE report 14944222 ↗
• MalfunctionFeb 25, 2022Positioning Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS DONE TO REPLACE (1) CALIBER SPACER THAT MOVED POSTERIORLY 1 MONTH POST OPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 13602854 ↗