BASE 6955202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887517701749), received between Jan 3, 2018 and May 14, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2018Break; Break

  ON (B)(6) 2017 PATIENT UNDERWENT A PROCEDURE USING THE BASE INTERFIXATED TITANIUM SYSTEM. ON (B)(6) 2018 DURING THE SIX MONTH FOLLOW UP, A SCREW FRACTURE WAS NOTED. PATIENT IS ASYMPTOMATIC.

  Patient problems: Failure of Implant

  MAUDE report 7512606 ↗
• MalfunctionMay 14, 2018Break; Break

  ON (B)(6) 2017 PATIENT UNDERWENT A PROCEDURE USING THE BASE INTERFIXATED TITANIUM SYSTEM. ON (B)(6) 2018 DURING THE SIX MONTH FOLLOW UP A SCREW FRACTURE WAS NOTED. PATIENT IS ASYMPTOMATIC.

  Patient problems: Failure of Implant

  MAUDE report 7512484 ↗
• MalfunctionJan 3, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2017 A PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE WITH POSTERIOR FIXATION AT L5-S1 LEVELS WITH NO REPORTED ISSUES. ON (B)(6) 2017 A FOLLOW UP RADIOGRAPH REVEALED ONE OF THE INFERIOR FIXATION SCREWS HAD BACKED OUT. NO REVISION PROCEDURE IS PLANNED AT THIS TIME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7162859 ↗