DELTA XTEND ITH003Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295257936), received between Jul 31, 2017 and Aug 22, 2024 — classified as 3 malfunctions.

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

• MalfunctionAug 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WASHER WAS MISSING THAT HOLDS THE 2 PARTS TOGETHER. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028091 ↗
• MalfunctionNov 18, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE HUMERAL STEM IMPACTOR THREADS ARE STRIPPED, NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10863057 ↗
• MalfunctionJul 31, 2017Component Missing; Component Missing

  IT WAS REPORTED THAT THE LOCKING NUT IS MISSING.

  Patient problems: No Information

  MAUDE report 6753329 ↗