DHS 280.900SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982176325), received between Dec 1, 2025 and Dec 1, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionDec 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A OSTEOSYNTHESIS OF THE PROXIMAL FEMUR, IT WAS IMPOSSIBLE TO IMPLEMENT A PLATE ON A SCREW. THE SURGEON CHANGED THE PLATE BUT IT DID NOT SOLVE THE ISSUE. THE SECOND PLATE - SAME PRODUCT CODE 02224223S (LOT: 63036P9) - ALSO DID NOT FIT ON THE SCREW ORIGINALLY INSTALLED (PRODUCT CODE 280900S - LOT: 45477P5). IN A SECOND STEP, THE SURGEON CHANGED THE CERVICAL SCREW INITIALLY INSTALLED AND REPLACED IT WITH A SCREW - PRODUCT CODE 280850S - LOT: 69122P9. THIS CHANGE ALLOWED THE COMPLETION OF THE PROCEDURE BY COUPLING THE SECOND PART NUMBER PLATE: 02224223S - LOT: 63036P9 WITH THE SCREW PART NUMBER: 280850S - LOT: 69122P9. THIS INCIDENT EXTENDED THE OPERATING TIME BY 30 MINUTES FROM THE USUAL 30 TO 45 MINUTES. IT EXPOSED THE PATIENT TO A RISK OF SEPSIS IN CONNECTION WITH THE VARIOUS MANIPULATIONS AND THE CONSEQUENT LENGTHENING OF THE OPERATING TIME.

  Patient problems: Insufficient Information

  MAUDE report 23686340 ↗