TWIN PEAKS 1 (REF 026HLC1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03663422600387), received between Feb 22, 2022 and Feb 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2022Nonstandard Device

  A NEW VERSION OF THE CAGE HOLDER 026HLC1 WAS RELEASED BEFORE THE NEW VERSIONS THE ASSOCIATED IMPACTORS 318HLP1 AND 378HLS1 WERE RELEASED. THE DESIGNS OF THE NEW CAGE HOLDER 026HLC1 IS NOT COMPATIBLE WITH THE PREVIOUS DESIGN OF THE IMPACTORS. IF THIS INSTRUMENT HAS REACHED THE SURGERY ROOM, IT WOULD HAVE NOT BEEN POSSIBLE TO IMPLANT THE LUMBAR CAGE. IN THAT CASE, AN INTERVENTION WOULD HAVE BEEN REQUIRED TO PREVENT PERMANENT DAMAGE (ABSENCE OF DISC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576118 ↗