DELTA XTEND 2307-72-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295116097), received between Feb 12, 2019 and Nov 30, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT THE MIDDLE HOLE OF THE CUTTING PLATE WOULDN'T ALLOW THE FIXATION PIN TO PASS. ON INSPECTION THE INTERNAL SURFACE WAS UNEVEN/SCARIFIED AS THOUGH IT HAS BEEN DAMAGED BY A PIN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? INSTRUMENT WAS PUT ASIDE AN NOT USED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY:UNKNOWN, (B)(4). DEVICE PROPERTY OF OTHER, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241731 ↗
• MalfunctionFeb 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE PIN BECAME STUCK IN CUTTING GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446755 ↗
• MalfunctionNov 26, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW ON INSTRUMENT WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378873 ↗
• MalfunctionFeb 12, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SCREWDRIVER IS BROKEN AND STRIPPING IMPLANTS AND THE CUTTING GUIDE IS WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331518 ↗