DELTA XTEND 2307-85-000Recalls & reported problems
Depuy (Ireland) · DELTA Xtend HUMERAL RESECTION PROTECTING PLATE · Class 1
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295116400), received between Mar 27, 2020 and Aug 4, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Entrapment of Device1
- Material Deformation1
Patient problems
- No Code Available2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED: WHAT DO YOU MEAN BY DAMAGE? WAS IT BROKEN INTO TWO OR MORE PIECES, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? THE TRAYS HAVE BEEN DAMAGED BY THE INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22702263 ↗MalfunctionJul 23, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE 38 POLY TRIALS ARE DAMAGED WITH SCARS AND MISSING PLASTIC IN AREAS SURGEON AND SPD WANTED THEM REPLACED. PROTECTIVE PLATE IS BENT AND WON¿T SIT FLUSH ON THE BONE. THE REAMERS ARE DULLED AND HAVE BURRS . THESE ITEMS WERE PULLED OUT OF THE SETS AND NOT USED IN A CASE.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10314386 ↗InjuryMar 27, 2020Entrapment of Device; Entrapment of Device
THIS COMPLAINT IS TO CAPTURE THE EVENT REPORTED IN (B)(4). IT WAS STATED THAT WHILE IN REVISION, IT WAS NOTICED THAT PART NUMBER 230785000 WAS IN THE JOINT FROM THE PRIOR SURGERY. DOE: (B)(6) 2020, RIGHT SHOULDER.
Patient problems: No Code Available
MAUDE report 9891496 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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