AVS 48350952LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327276817), received between Oct 29, 2022 and Nov 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 18, 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.

• MalfunctionNov 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT WITH NEUROLOGICAL SYMPTOMS WAS REVISED APPROXIMATELY 2.5 YEARS POST-OPERATIVELY TO ADDRESS TWO MIGRATED TRITANIUM POSTERIOR LUMBAR CAGES (ADDRESSED IN PI (B)(4)). WHILE ATTEMPTING TO REMOVE THE TWO LUMBAR CAGES WITH AN AVS SPACER INSERTER, BOTH CAGES FRACTURED AND THE INSERTER DEFORMED INTRA-OPERATIVELY. THE FRACTURED COMPONENTS OF THE CAGES WERE EXPLANTED, HOWEVER THE REST OF THE CAGES REMAINED IMPLANTED. THE CAGE SURFACES WERE SMOOTHED AND DECOMPRESSION WAS SUCCESSFULLY COMPLETED TO ALLEVIATE THE NEUROLOGICAL SYMPTOMS. THIS REPORT CAPTURES THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747613 ↗
• MalfunctionOct 29, 2022Material Deformation; Material Deformation

  THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE AVS PL STRAIGHT INSERTER DEFORMATION. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695986 ↗