ISOLARecalls & reported problems across all models
Depuy Spine, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 8 models of ISOLA by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2017 and Jan 13, 2026 — classified as 2 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ISOLA problems
Device problems
- Break35
- Material Integrity Problem9
- Detachment of Device or Device Component1
- Device Slipped1
- Device-Device Incompatibility1
- Entrapment of Device1
- Illegible Information1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient7
- Insufficient Information4
- Cerebrospinal Fluid Leakage1
- No Known Impact Or Consequence To Patient1
- Pain1
- Paralysis1
- Spinal Cord Injury1
ISOLA models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ISOLA 205027INSTRUMENT, CUTTING, ORTHOPEDIC21 reports
- ISOLA 205030INSTRUMENT, CUTTING, ORTHOPEDIC9 reports
- ISOLA 203014Orthosis, spondylolisthesis spinal fixation3 reports
- ISOLA 205050WRENCH3 reports
- ISOLA 205028ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ISOLA 2050285ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ISOLA 2050286ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- ISOLA 205197SCREWDRIVER1 report
Recent ISOLA adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 18, 2025Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21405472 ↗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 ↗
Other Depuy Spine, LLC products
All Depuy Spine, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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