ISOLA 205028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034001265), received between May 14, 2019 and Mar 4, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

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.

• MalfunctionMar 4, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A POSTERIOR FUSION (IN L5-PEDICLE) TREATING A SPINAL CANAL STENOSIS, THE PROBE (279702040) AND THE PEDICLE MARKER (205028) WERE DEFORMED WHILE A BURR HOLE WAS BEING MADE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. THIS REPORT IS FOR ONE BONE MARKER ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787130 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED THAT THE TLIF SURGERY WAS PERFORMED DUE TO LUMBAR SPONDYLOLISTHESIS TO FIX L4/5 ON (B)(6) 2019. DURING THE SURGERY, A FOREIGN MATERIAL LIKE A NEEDLE CAME OUT FROM THE MAKER HOLDER. THE SURGERY WAS COMPLETED BY HOLDING THE BONE MAKER WITH ANOTHER INSTRUMENT. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8607254 ↗