PROSPACE® XP SO147PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964073717), received between Nov 29, 2021 and Nov 29, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Fracture; Fracture

  UPDATE: THE PROCEDURE WAS PERFORMED AT LEVEL L5-S1. THE PATIENT HAD SPINAL CANAL STENOSIS WITH NARROWING BETWEEN VERTEBRAL BODIES. IT WAS NOTED THAT USING A 7MM SHAVER DISTRACTOR ALONE WAS DIFFICULT, SO A CLAW- SHAPED DISTRACTOR WAS USED TO OPEN AND THEN LIFTED WITH 7MM. CAGE WAS INSERTED AFTER DISSECTION AND BONE FILLING. AT THE TIME OF INSERTING THE CAGE, THE IMAGE WAS CONFIRMED AND THE IMAGE WAS DRIVEN IN, AND THE MARKER POSITION AND THE INSERTER POSITION BECAME AN UNNATURAL IMAGE FROM THE MIDDLE. THE DAMAGED DEBRIS WAS COLLECTED AND THE TIP OF THE INSERTER WAS CONFIRMED TO BE DAMAGED. THE INSERTER ITSELF WAS NOT DAMAGED AND THE CAGE TIP 1/3 REMAINED IN THE PATIENT'S VERTEBRAL BODY. THE DOCTOR TRIED TO REMOVE IT USING A SPECIAL REMOVER, BUT IT WAS DIFFICULT TO REMOVE IT. FINALLY, THE TRAILING EDGE OF THE VERTEBRAL BODY WAS SCRAPED WITH A CHISEL AND OPENED USING A INGE LAMINA SPREADERS. THEN, IT WAS POSSIBLE TO RECOVER THE TIP OF THE CAGE BY REMOVING IT AGAIN WITH A SPECIAL REMOVER. AFTER THAT, THE SAME SIZE WAS INSTALLED IN THE OPEN STATE WITH A INGE LAMINA SPREADERS, AND IT WAS COMPLETED WITHOUT ANY PROBLEM.

  Patient problems: Failure of Implant

  MAUDE report 12888081 ↗