XIA IS2739XLP01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327279313), received between Nov 8, 2016 and Jul 31, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2017Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF THE PROBE WAS BROKEN ABOUT 8 MM FROM THE TIP WHEN IT WAS INSERTED TO TH10 LEFT. THE BROKEN PART WAS REMAIND TO THE PATIENT. THE CASE WAS L1 BURST FRACTURE, TH10-L3 WERE FIXED. THE SURGEON IS WORRIED ABOUT THE INFLUENCE WHEN MRI EXAMINATION IS PERFORMED. UPDATE (B)(6) 2017: A LITERATURE SEARCH WAS CONDUCTED TO EVALUATE THE POTENTIAL FOR MAGNETIC FIELD INTERACTIONS FOR SPINAL IMPLANTS OF VARYING MATERIALS (INCLUDING STAINLESS STEEL) AND DEMONSTRATED SAFETY IN DEFINED MAGNETIC RESONANCE CONDITIONS. NO ADVERSE EVENTS RELATED TO MRI PROCEDURES HAVE BEEN REPORTED FOR SPINE IMPLANTS.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6755679 ↗
• MalfunctionNov 8, 2016Fracture; Material Integrity Problem; Fracture; Difficult to Remove; Metal Shedding Debris; Material Integrity Problem

  IT WAS REPORTED THAT; ATTEMPTED TO INSERT THE SCREW AFTER DRILLING ON RIGHT PEDICLE L5. THERE WAS FOUND SOMETHING A METAL PIECE UNDER X RAY. THERE FOUND A FRACTURE PIECE OF BY XRAY . IT COULDN'T BE REMOVED OUT OF PATIENT BODY. FINALIZED THE PROCEDURE, BUT THE METAL PIECE REMAINED IN THE PATIENT BODY.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6087426 ↗