CASCADIA™ Interbody System 6101-90164Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888857283350), received between Aug 31, 2021 and Jul 29, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF AN INTRAOPERATIVE CASCADIA TL INSERTER/IMPACTOR COUPLING ISSUE. 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 15135578 ↗
• MalfunctionJan 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A CASCADIA TL INSERTER/IMPACTOR WAS STUCK INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND ANOTHER INSERTER. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211762 ↗
• MalfunctionOct 1, 2021Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED BY THE DISTRIBUTOR THAT THE INNER SHAFT WAS UNABLE TO BE INSERTED INTO THE HANDLE AS THE THERE WAS A SLIGHT BEND ON THE HANDLE ITSELF. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562732 ↗
• MalfunctionAug 31, 2021Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  IT WAS REPORTED BY THE DISTRIBUTOR THAT CASCADIA TL INSERTER/IMPACTOR WAS FOUND TO BE FAULTY DURING INSPECTION BEFORE SURGERY BEGAN. UNABLE TO INSERT INNER SHAFT 'BEND' ON THE INNER SIDE OF THE HANDLE. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12398778 ↗