XIA 3 48237081Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327265590), received between Jan 20, 2017 and Dec 17, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  PEDICLE MARKER BROKE WHEN REMOVING THE MARKER, AND A PART OF THE BROKEN MARKER PIN REMAINED IN THE BODY. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8168846 ↗
• MalfunctionDec 11, 2018Fracture; Break; Fracture

  THE PEDICLE MARKER THAT WAS INSERTED AT S1 LEVEL (LEFT) BROKE WHEN INSERTING THE L5 LEFT SCREW. SURGEON REMOVED THE BROKEN MARKER, CONTINUED THE OPERATION, IMPLANTED ALL THE SCREWS AND FINISHED THE OPERATION SUCCESSFULLY. ALL BROKEN FRAGMENTS WERE RETRIEVED AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8150151 ↗
• MalfunctionOct 17, 2018Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT AN L5/S1 PLIF PROCEDURE WAS PERFORMED FOR L5 SPONDYLOLYTIC SPONDYLOLISTHES. THE PEDICLE MARKER WAS INSERTED TO INSERT A PEDICLE SCREW. IN THE LAST IMAGE TAKEN AFTER SUTURING, THE SURGEON CONFIRMED THAT THE TIP OF THE MARKER WAS LEFT ON THE LEFT OF S1. THEREFORE, THE WOUND WAS RE-OPENED TO RETRIEVE AND REMOVE THE FRAGMENT. THERE WAS A REPORTED 30 MINUTE DELAY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7975708 ↗
• MalfunctionAug 20, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE PEDICLE MARKER WAS PUSHED INTO THE PATIENT BROKE. THE MARKER WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THERE WAS NO INTERVENTION OR ADVERSE CONSEQUENCES. THERE WAS A 10-15 MINUTE DELAY. THE REPRESENTATIVE PRESENT DURING THE CASE WAS INFORMED THAT THE STAFF DISPOSED OF THE MARKER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7796853 ↗
• MalfunctionMar 7, 2018Fracture; Break; Entrapment of Device; Fracture

  IT IS REPORTED THAT THE PEDICLE MARKER BROKE OFF INTO THE PEDICLE OF R L3 VERTEBRAE. SURGEON BELIEVES THE PROXIMAL END OF MARKER GOT CAUGHT ON RETRACTOR CAUSING IT TO BREAK OFF INTO PATIENT. NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322755 ↗
• MalfunctionJun 12, 2017Break; Fracture; Difficult to Remove; Fracture

  IT WAS REPORTED THAT; SURGEON MARKED HIS PEDICLES WITH PEDICLE MARKERS. WHEN THEY TOOK A LATERAL X-RAY TO CONFIRM THE LOCATION WE NOTICED THE PEDICLE IN L4 WAS BROKEN OFF. HE COULD NOT RETRIEVE THE BROKEN TIP FROM THE PEDICLE AND LEFT IT IN THE PATIENT.

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

  MAUDE report 6635403 ↗
• MalfunctionMar 16, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY, THE PEDICLE MARKER BROKE AT LEFT SIDE L5 WHEN THE SURGEON WAS INSERTING THE MARKER INTO THE PEDICLE. THE SURGEON TILTED THE HOLDER TO DISTAL DURING THE INSERTION. AFTER THAT, THE BROKEN PART WAS REMOVED. THE SURGEON USED THE OTHER MARKER AND CONTINUED THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6410834 ↗
• MalfunctionJan 20, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF THE MARKER BROKE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT. THE BONE QUALITY WAS HARD AND THE SURGEON HIT THE MARKER INTO THE BONE BY THE HAMMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6267855 ↗