DELTA XTEND 2307-10-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295115557), received between Apr 19, 2023 and Apr 19, 2023 — 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 18, 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 19, 2023Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE HOSPITAL HAVE SOME DELTA XTEND INSTRUMENTS THAT NEED TO BE EXCHANGED DUE TO GENERAL WEAR AND TEAR, DETAILS ARE AS FOLLOWS: 3.5 MM CANNULATED HEX SCREWDRIVER. GENERAL WEAR AND TEAR OVER TIME, THE HEX IS NOW MISSHAPEN AND DUE TO IT BECOMING MORE ROUNDED, DOES NOT GRIP AND ENGAGE WITH THE SCREW SUFFICIENTLY TO TIGHTEN IT. MODULAR HUMERAL STEM TRIAL Ø 10 MM. THE PROXIMAL PART OF THE TRIAL STEM HAS BEEN IMPACTED OVER TIME CAUSING THE CURVATURE OF THE HOLE TO BE SLIGHTLY MISSHAPEN. THIS, HOWEVER, MAKES IT EXTREMELY DIFFICULT TO INSERT THE EPIPHYSIS ONTO THE TRIAL STEM. WITH A LOT OF FORCE, THE EPIPHYSIS CANNOT BE FULLY INSERTED, MEANING THAT IT DOES NOT SIT FLUSH AGAINST THE STEM. TRAILING IS THEREFORE INACCURATE. SIZE 2 LEFT EPI TRIAL. INSERTION POST DAMAGED TRYING TO INSERT INTO ABOVE BROKEN TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768802 ↗