ISOLA 205027Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034001258), received between Feb 21, 2018 and Jan 13, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE TIP OF A FINE TIPPED "BERBECKER" ROD CUTTER HAD BEEN CHIPPED WHILE IN THE PROCESS OF CUTTING A ROD. THERE WAS NO PATIENT HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057504 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION.TWO FINE TIPPED BERBACKERS HAD BEEN PUT ASIDE DUE TO CHIPPED TIPS FROM CUTTING RODS IN THE OR. AS WELL, A THIRD BERBECKER CHIPPED DURING IN-SITU ROD CUTTING IN THE OR THAT SAME DAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INCIDENT AND NO ADDITIONAL TIME ADDED TO THE PROCEDURE. A NEW BEBERCKER ROD CUTTER WAS CALLED TO THE OR TO REPLACE THE CHIPPED ONE. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350168 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION.TWO FINE TIPPED BERBACKERS HAD BEEN PUT ASIDE DUE TO CHIPPED TIPS FROM CUTTING RODS IN THE OR. AS WELL, A THIRD BERBECKER CHIPPED DURING IN-SITU ROD CUTTING IN THE OR THAT SAME DAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INCIDENT AND NO ADDITIONAL TIME ADDED TO THE PROCEDURE. A NEW BEBERCKER ROD CUTTER WAS CALLED TO THE OR TO REPLACE THE CHIPPED ONE. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350164 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION.TWO FINE TIPPED BERBACKERS HAD BEEN PUT ASIDE DUE TO CHIPPED TIPS FROM CUTTING RODS IN THE OR. AS WELL, A THIRD BERBECKER CHIPPED DURING IN-SITU ROD CUTTING IN THE OR THAT SAME DAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INCIDENT AND NO ADDITIONAL TIME ADDED TO THE PROCEDURE. A NEW BEBERCKER ROD CUTTER WAS CALLED TO THE OR TO REPLACE THE CHIPPED ONE. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350159 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT TWO FINE TIPPED BERBECKER ROD CUTTERS HAD BEEN CHIPPED DUE TO USE IN THE OR OVER THE PAST SEVERAL WEEKS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN ON WHAT DATE THE DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936541 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT TWO FINE TIPPED BERBECKER ROD CUTTERS HAD BEEN CHIPPED DUE TO USE IN THE OR OVER THE PAST SEVERAL WEEKS. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN ON WHAT DATE THE DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936461 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON USED THE REPORTED BOLT CUTTER INTRAOPERATIVELY TO CUT A 5.5 MM TITANIUM ROD OF THE EXPEDIUM 5.5 SYSTEM. WHEN APPLYING FORCE TO THE INSTRUMENT TO CUT THE ROD, ONE OF THE THICK, FIXING SCREWS/BOLTS AT THE TOP END OF THE INSTRUMENT BROKE BELOW THE CUTTING SURFACES. THERE WAS NO PATIENT HARM, NO PATIENT CONSEQUENCES, AND NO MEDICAL INTERVENTION REQUIRED. THE OPERATION WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875789 ↗
• MalfunctionFeb 7, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE TIPS OF TWO (2) ISOLA SIDE ROD CUTTERS ARE CHIPPED OVER TIME AND WERE NO LONGER ABLE TO PROPERLY CUT THE RODS USED IN SPINAL PROCEDURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338237 ↗
• MalfunctionFeb 7, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE TIPS OF TWO (2) ISOLA SIDE ROD CUTTERS ARE CHIPPED OVER TIME AND WERE NO LONGER ABLE TO PROPERLY CUT THE RODS USED IN SPINAL PROCEDURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338235 ↗
• InjuryOct 4, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO BROKEN FRAGMENTS RETAINED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20370929 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CUTTER SNAPPED WHILE CUTTING A ROD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE IS ROD SIDE CUTTER.

  Patient problems: Insufficient Information

  MAUDE report 20370734 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY ON HEEL ON (B)(6) 2024. IN THE SURGERY, THE TIP OF THE IS ROD SIDE CUTTER BROKE OFF WHEN THE SURGEON CUT THE TRAUMA SCREW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME THIS REPORT IS FOR ONE (1) ISOLA SPINE SYSTEM ROD CUTTER (SIDE). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19506088 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY ON (B)(6) 2024, THE SURGEON WENT TO USE THE ROD CUTTER AND IT BROKE. THE PIN HOLDING THE ROD TOGETHER CAME OUT. NO FRAGMENTS WERE GENERATED; THE PIECES WERE FOUND COMPLETE. THE ROD CUTTERS WERE TOTALLY NON-USABLE. ANOTHER ROD CUTTER WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE ISOLA SPINE SYSTEM ROD CUTTER (SIDE). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115015 ↗
• MalfunctionMar 27, 2024Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING LOAN KIT INSPECTION, IT WAS DISCOVERED THAT THE ROD CUTTER IN QUESTION WAS DAMAGED. THE CUTTER ON THE PRODUCT IS CHIPPED. THERE WAS NO PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN ISOLA SPINE SYSTEM ROD CUTTER (SIDE). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987662 ↗
• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 THE RODE SIDE CUTTER WAS FOUND BROKEN. THE CUTTER CAME APART WHEN THE PINS THAT HOLD IT TOGETHER POPPED OUT. THE EVENT OCCURRED IMMEDIATELY POST PROCEDURE, THERE WAS NO ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR AN ISOLA SPINE SYSTEM ROD CUTTER (SIDE). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764614 ↗
• InjuryAug 29, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2022, THE PATIENT UNDERWENT SPINAL SURGERY AND WHILE THE SURGEON WAS CUTTING A TITANIUM ROD IN PATIENT'S BACK, THE SPINAL ROD CUTTER WAS FRACTURED AND A FRAGMENT OF THE BLADE PENETRATED HIS DURA AND SPINAL CORD CAUSING HIS PERMANENT PARALYSIS. CONCOMITANT DEVICE: UNKNOWN TITANIUM ROD (PRODUCT CODE: UNK, LOT#: UNK, QTY:UNK). THIS REPORT IS FOR ONE (1) IS ROD SIDE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Cerebrospinal Fluid Leakage; Pain; Paralysis; Spinal Cord Injury

  MAUDE report 17640815 ↗
• MalfunctionJul 31, 2023Detachment of Device or Device Component; Illegible Information; Detachment of Device or Device Component; Illegible Information

  IT WAS REPORTED DURING A SPINAL FUSION PROCEDURE ON (B)(6) 2023 THERE WAS AN ISSUE WITH A ROD CUTTER. THE SURGEON WAS USING THE ISOLA SIDE ROD CUTTER AND AS HE WAS CLOSING THE CUTTER ARMS THE MOUTH OF THE CUTTER CAME APART. ANOTHER SET WAS OPENED AND HE USED THAT ONE TO CUT THE ROD. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO KNOWN PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: EXPEDIUM CORE INSTRUMENTS - SURGEON (PART# ZNAUSP9200; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE ISOLA SPINE SYSTEM ROD CUTTER FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423939 ↗
• MalfunctionMar 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ROD CUTTER WAS PUT ASIDE AND LEFT FOR REP TO PICK UP. THERE WAS NO INFORMATION WITH REGARD TO THE EVENT THAT LED TO THE BROKEN/CHIPPED TIP. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) IS ROD SIDE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462078 ↗
• MalfunctionAug 26, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT THE PATIENT UNDERWENT A PARTIAL REMOVAL PROCEDURE IN THE POSTERIOR FUSION (TH10-12). THE VERSE SYSTEM WAS APPLIED. WHILE A ROD WAS BEING CUT, THE TIP OF THE GIANT ROD CUTTER BROKE. NO FRAGMENT WAS IN THE PATIENT¿S BODY. THIS REPORT INVOLVES ONE (1) ISOLA SPINE SYSTEM ROD CUTTER (SIDE). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370872 ↗
• MalfunctionMay 10, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE CUTTING BLADES OF THE ROD CUTTER WERE NOT CUTTING ANYMORE. THERE WAS NOT PATIENT OR PROCEDURE IMPACT. UPON VISUAL INSPECTION OF THE RECEIVED DEVICE, IT IS OBSERVED THAT ONE CORNER OF THE CUTTING EDGES GOT SLIGHTLY BROKEN. REST OF THE CUTTING EDGES GOT SLIGHTLY WORN. THIS REPORT IS FOR A ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801529 ↗
• MalfunctionFeb 21, 2018Break; Break

  CUTTING ARE AT THE TIP OF INSTRUMENT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286165 ↗