ISOLA 205030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705034001289), received between Mar 15, 2021 and Feb 18, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21405472 ↗
• MalfunctionFeb 28, 2023Break; Device Slipped; Use of Device Problem; Break; Device Slipped; Use of Device Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING A LUMBAR FUSION PROCEDURE USING A LOAN EXPEDIUM SET, WHEN THE TABLE TOP ROD CUTTER WAS OPENED ONTO THE STERILE FIELD, IT WAS NOTED TO PIVOT SIDEWAYS NEAR THE CUTTING SECTION WHERE IT SHOULD NOT PIVOT SIDE WAYS. THIS CUTTER WAS PLACED TO THE SIDE AND NOT USED. A SECOND CUTTER WAS OPENED AND USED INSTEAD. AFTER THE CASE IT WAS NOTICED THAT THERE WAS A SCREW MISSING FROM UNDERNEATH THE CUTTER WHICH HAS CAUSED IT TO COME LOOSE AND PIVOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) ISOLA SYSTEM TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456342 ↗
• MalfunctionJan 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS IT WAS REPORTED THAT THIS WAS A POSTERIOR THORACOLUMBAR FUSION FOR THE AIS ON (B)(6) 2022. THE ROD WAS CUT WITH THE ROD CUTTER. THE ROD CUTTER ITSELF WAS BROKEN WHEN THE LEVER WAS PUSHED DOWN. WHEN THE SURGEON MOVED THE ROD CUTTER FOR REMOVING THE ROD, THE INSIDE PARTS CAME OUT IN PIECES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) IS TABLE TOP ROD CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16198917 ↗
• MalfunctionDec 20, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TABLE TOP ROD CUTER WOULD NOT CUT THE ROD AND BROKE. A SECOND CUTTER WAS RETRIEVED, THEREFORE, NO IMPACT TO THE CASE AND NO SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) IS TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017907 ↗
• MalfunctionJun 9, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 A TABLE TOP ROD CUTTER BROKE WHILE CUTTING THE ROD, IT APPEARS THERE WAS A SCREW MISSING FROM THE POINT WHERE THE CUTTING HEAD MEETS THE BASE (ONLY ONE SCREW PRESENT) THE SINGLE SCREW SHEARD AND BROKE WHILE TRYING TO CUT A ROD. WE HAD AN ALTERNATIVE SO CASE WENT AHEAD OK. THIS REPORT IS FOR ONE (1) IS TABLE TOP ROD CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645958 ↗
• MalfunctionDec 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, DURING A PROCEDURE THE BLADE INSIDE THE CUTTER WAS BROKEN AND WOULD NOT CUT THE ROD. A SECOND ROD CUTTER WAS USED. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) ISOLA SYSTEM TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010069 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE INSTRUMENT COORDINATOR ORDERED A ROD CUTTER ON SEP 10TH. THIS CUTTER IS ALREADY TAGGED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) IS TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800164 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT, THE ROD CUTTER WAS BROKEN. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) ISOLA SYSTEM TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586801 ↗
• MalfunctionMar 15, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE ROD CUTTER FAILED TO CUT THE ROD, THE ROD CUTTER BLADES APPEARED TO MOVE OUT OF ALIGNMENT. A NEW ROD CUTTER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOMES. THIS REPORT INVOLVES ONE (1) ISOLA SYSTEM TABLE TOP ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482918 ↗