Stratum STRM-LAP-SMRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817701025467), received between Dec 20, 2019 and Jan 7, 2020 — classified as 2 malfunctions.

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

• MalfunctionJan 7, 2020Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A STRATUM FOOT PLATING SYSTEM STRM-LAP-SMR (STRATUM LAPIDUS PLATE -SMALL RT) PACKAGE WAS FOUND TO CONTAIN AN STRM-LAP-SML (STRATUM LAPIDUS PLATE - SMALL LT). THE INCORRECT PLATE WAS DISCOVERED BY A SALES REPRESENTATIVE PRIOR TO THE SCHEDULED SURGERY. A REPLACEMENT STRM-LAP-SMR PLATE WAS OBTAINED. THERE WAS NO AFFECT ON THE SURGERY OR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9559896 ↗
• MalfunctionDec 20, 2019Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A STRATUM FOOT PLATING SYSTEM STRM-LAP-SMR (STRATUM LAPIDUS PLATE - SMALL RT) PACKAGE WAS OPENED AND FOUND TO CONTAIN A STRM-LAP-SML (STRATUM LAPIDUS PLATE - SMALL LT). THE SURGEON SELECTED AN ALTERNATE PLATE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9505713 ↗