ISOLA 205050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034001449), received between Aug 3, 2017 and Oct 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE REMOVAL SURGERY OF ISOLA SCREWS, THE TIP OF THE SCREWDRIVER BROKE. THE SURGEON USED A DIFFERENT SCREWDRIVER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335544 ↗
• MalfunctionFeb 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THIS WAS A REMOVAL SURGERY PERFORMED FOR THE SCOLIOSIS PATIENT DONE IN 2007. WHEN THE HOOK SET SCREW WAS REMOVED, THE HOOK WAS EXCESSIVELY ADHERENT. THEN, THE HOOK SET SCREW THREADED OFF AND STUCK IN THE SCREWDRIVER. A NEW SCREWDRIVER WAS USED INSTEAD OF THE SCREWDRIVER IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING/SET SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) IS SET SCW HEXDRIVER 1/8 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294904 ↗
• MalfunctionAug 3, 2017Break; Break

  IT WAS REPORTED THAT DURING THE SET UP OF INSTRUMENTS AND PRIOR TO PATIENT ENTERING THE ROOM FOR A LUMBAR DECOMPRESSION AND FUSION SURGERY, THE SCRUB NURSE NOTED THAT THE TIP OF THE INSTRUMENT, THE SCREW DRIVER TIP WAS MISSING AND COMPLETELY BROKEN OFF. COMPLETED WITH SAME/LIKE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764218 ↗