Foot Plates SP-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188120121), received between Apr 24, 2026 and Apr 24, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 24, 2026Insufficient Device Problem Information

  FOREIGN DISTRIBUTOR REPORTED ON (B)(6) 2026 THAT A LOCKING SCREW WAS IMPLANTED TO FIX THE SP-6 PLATE BUT FAILED TO LOCK INTO THE PLATE (RX ATTACHED). IT WAS STATED THAT THE SURGEON REPLACED THE PLATE WITH ANOTHER SP-6 AND RE-USED THE SAME SCREWS; FIXATION WAS SUCCESSFUL. THEREFORE, SHE BELIEVES THE DEFECT IS ATTRIBUTED TO THE THREAD OF THE ORIGINAL PLATE. IT WAS REPORTED THAT THE DEVICE CAME IN CONTACT WITH THE PATIENT PER PLANNED PROCEDURE, THERE WAS OVER A 20-MINUTE DELAY TO SWAP OUT THE PLATE HOWEVER THIS DID NOT CAUSE ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: Oversedation

  MAUDE report 24985679 ↗