Medtronic Reusable InstrumentsRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 107
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 36 models of Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 107 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Sep 28, 2026 — classified as 15 injuries, 92 malfunctions.
The most frequently reported specific device problem is “Break” (76 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 Medtronic Reusable Instruments problems
Device problems
- Break76
- Material Deformation7
- Scratched Material5
- Adverse Event Without Identified Device or Use Problem4
- Crack4
- Material Twisted/Bent3
- Mechanics Altered3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- No Known Impact Or Consequence To Patient11
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient2
- Blood Loss1
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
- Paralysis1
Medtronic Reusable Instruments models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Medtronic Reusable Instruments 2990001Intervertebral fusion device with bone graft, lumbar29 reports
- Medtronic Reusable Instruments 2900163CURETTE, SURGICAL, GENERAL USE11 reports
- Medtronic Reusable Instruments 873-007BIT, DRILL7 reports
- Medtronic Reusable Instruments 9560547CURETTE, SURGICAL, GENERAL USE7 reports
- Medtronic Reusable Instruments 8530630SCREWDRIVER5 reports
- Medtronic Reusable Instruments 9411200SPINAL VERTEBRAL BODY REPLACEMENT DEVICE4 reports
- Medtronic Reusable Instruments 3990003Intervertebral fusion device with bone graft, lumbar4 reports
- Medtronic Reusable Instruments 3990004Intervertebral fusion device with bone graft, lumbar3 reports
- Medtronic Reusable Instruments 907347CURETTE, SURGICAL, GENERAL USE3 reports
- Medtronic Reusable Instruments 2986845Intervertebral fusion device with bone graft, lumbar2 reports
- Medtronic Reusable Instruments 9412500SPINAL VERTEBRAL BODY REPLACEMENT DEVICE2 reports
- Medtronic Reusable Instruments 9411905SPINAL VERTEBRAL BODY REPLACEMENT DEVICE2 reports
- Medtronic Reusable Instruments 875-304CURETTE, SURGICAL, GENERAL USE2 reports
- Medtronic Reusable Instruments 8670020SCREWDRIVER2 reports
- Medtronic Reusable Instruments 5485930Orthopedic manual surgical instrument2 reports
- Medtronic Reusable Instruments 9569602Orthopedic manual surgical instrument2 reports
- Medtronic Reusable Instruments X0925004SCREWDRIVER1 report
- 1 report
- Medtronic Reusable Instruments 8114505INSTRUMENT, BENDING OR CONTOURING1 report
- Medtronic Reusable Instruments 9391300SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- Medtronic Reusable Instruments EX0810680Orthopedic manual surgical instrument1 report
- Medtronic Reusable Instruments EX1111549SCREWDRIVER1 report
- 1 report
- Medtronic Reusable Instruments 9560546CURETTE, SURGICAL, GENERAL USE1 report
- Medtronic Reusable Instruments X873-207BIT, DRILL1 report
- Medtronic Reusable Instruments 6905774Orthopedic manual surgical instrument1 report
- 1 report
- Medtronic Reusable Instruments 7480118SCREWDRIVER1 report
- Medtronic Reusable Instruments 9561523Orthopedic manual surgical instrument1 report
- Medtronic Reusable Instruments EX0418002CHISEL (OSTEOTOME)1 report
- 1 report
- Medtronic Reusable Instruments X5599120SCREWDRIVER1 report
- Medtronic Reusable Instruments X5597185SCREWDRIVER1 report
- Medtronic Reusable Instruments X1004003Orthopedic manual surgical instrument1 report
- Medtronic Reusable Instruments 2980008Orthopedic manual surgical instrument1 report
- Medtronic Reusable Instruments 9569601Orthopedic manual surgical instrument1 report
Recent Medtronic Reusable Instruments adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
Information was received from the Health care professional via a manufacturer representative regarding a device used for 2 level Anterior Cervical Discectomy Fusion procedure.Pre-operative diagnosis was patient had spinal stenosis.It was reported that while instrumenting the screw the tip of the driver broke off inside the screw head. The surgeon was able to remove the metal fragment and no harm was done to the patient. There were no patient symptoms reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911426 ↗MalfunctionAug 13, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232373 ↗MalfunctionAug 5, 2026Break; Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137334 ↗MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049588 ↗MalfunctionApr 27, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR MICROENDOSCOPIC DISCECTOMY. IT WAS REPORTED THAT IT WAS A PRODUCT THAT WAS PURCHASED LAST MONTH AND WHEN USED FOR THE FIRST TIME DURING THIS OPERATION, IT WAS BENT USING A LIGHT FORCE. THE DEVICE WAS BENT, SO IT COULD NOT BE USED; IT WAS DEALT WITH BY USING SOMETHING ELSE. WHEN THE BENT PART WAS RETURNED, IT BROKE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PRODUCT WAS NOT BENT AT THE TIME OF DELIVERY. IT WAS SAID THAT IT BROKE DURING THE VERY FIRST USE IN SURGERY. IT REPORTEDLY BROKE WITHOUT APPLYING MUCH FORCE. THIS APPEARS TO BE THE FIRST OCCURRENCE, INCLUDING LOANER INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994896 ↗MalfunctionApr 10, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L4-L5 REVISION AND REMOVAL OF EXISTING HARDWARE SOLERA 4.75 PEDICAL SCREWS AND ADAPTIX INTERBODY. SURGEON EXPOSED PATIENT REMOVING OLD SOLERA 4.75 SET SCREWS, RODS, AND PEDICLE SCREWS. SURGEON THEN EXPOSED TO THE EXISTING ADAPTIX INTERBODY AND TRIED TO ATTACH AND REMOVE WITH ORIGINAL ADAPTIX INSERTER. IT WAS REPORTED THAT SURGEON WAS REMOVING EXISTING ADAPTIX INTERBODY WITH PROPER INSERTER (2990001) HE THOUGHT IT WAS ATTACHED TO EXISTING INTERBODY IN PATIENT SO HE TWIST THE INSTRUMENT AND BROKE ONE OF THE TIPS OFF THAT ATTACHES AROUND THE IMPLANT. SURGEON DID MALLET THE INSERTER BEFORE TWISTING EVEN THOUGH HE WAS ADVISED NOT TO MALLET THE INSTRUMENT PER TECHNIQUE. BROKEN TIP WAS REMOVED FROM PATIENT AND BROKEN INSERTER WAS REMOVED FROM SURGICAL FIELD. INTERBODY WAS REMOVED USING A UNIVERSAL REMOVAL TOOL MAKING SURE ALL AND EVERYTHING WAS REMOVED FROM THE PATIENT. SURGEON TOOK A 3D IMAGE USING O-ARM CHECKING NOTHING REMAINED IN THE PATIENT. SURGEON THEN PLACED NEW ADDITIONAL SOLERA 4.75 PEDICLE SCREWS, RODS, AND SETSCREWS. FINALLY SURGEON PERFORMED ANOTHER 3D IMAGE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24840632 ↗MalfunctionMar 24, 2026Break
INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE REMOVING AN OLD IMPLANT, THE INSERTER TIP BROKE AND THERE ARE NO BROKEN FRAGMENTS LEFT INSIDE PATIENT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680073 ↗MalfunctionMar 11, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY. IT WAS REPORTED THAT AFTER INSERTING THE CAGE AND REMOVING THE INSERTER, IT WAS NOTICED THAT THE TIP WAS DAMAGED. THE INSERTED CAGE WAS TEMPORARILY REMOVED, AND IMAGING REVEALED THE FRAGMENT INSIDE THE INTERVERTEBRAL DISC WHICH WAS REMOVED USING A HERNIA FORCEPS. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT INSERTER WAS BROKEN AND SEPARATED STATE AT 6 MM FROM THE TIP OF THE DISTAL PART. WHEN THE INSERTER AND CAGE BETWEEN THE VERTEBRAE WERE INSERTED AND THE INSERTER WAS REMOVED, THE TIP WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575097 ↗MalfunctionMar 2, 2026Break
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL PROCEDURE. IT WAS REPORTED THAT THE SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED R EGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480239 ↗MalfunctionJan 21, 2026Break
INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING PRODUCTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE PREPPING FOR SURGERY, THE INSTRUMENTS WERE DROPPED ON FLOOR AND GOT BROKEN. THERE IS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24128385 ↗MalfunctionJan 16, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L4/5TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L4/5 LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT WHEN USING THE CURETTE TO DISSECT AROUND THE INFERIOR ARTICULAR PROCESS OF L4, THE HANDLE BROKE. THE FRACTURE OCCURRED AT THE PART WHERE THERE IS A HOLE, AND THE PHYSICIAN SPECULATED THAT THE LOWER POSITION OF THE HOLE COMPARED TO BEFORE MAY HAVE BEEN THE CAUSE. ISSUE OCCURRED IN A NEW PRODUCT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092223 ↗MalfunctionDec 29, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY SPINAL THERAPY FOR L4 DEGENERATIVE SPONDYLOLISTHESIS TO L4/5 LEVELS. IT WAS REPORTED THAT AN AA 24×10 MM CAGE WAS INSERTED AT L4/5. AFTER REMOVING THE INSERTER, A SLIGHT INWARD TILT OF THE CAGE WAS REQUESTED. THE INSERTER WAS REINTRODUCED INTO THE DISC SPACE, AND THE INNER SHAFT WAS ROTATED SEVERAL TIMES TO ADJUST. A ¿CLICK¿ WAS HEARD, AND UPON REMOVAL, ONE TINE OF THE BIFURCATED INSERTER TIP WAS MISSING. THE FRAGMENT WAS RETRIEVED FROM THE BODY USING A PUNCH AND FORCEPS IN APPROXIMATELY 2 MINUTES. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE SIGNS OF WEAR ON THE THREADS APPROXIMATELY 2.3 CM FROM THE HEAD FOR PLI 20.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919247 ↗MalfunctionDec 11, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE DRIVER WAS BEING USED TO BREAK OFF REDUCTION SET SCREWS WHEN THE HANDLE OF THE DRIVER BROKE OFF, CREATING A SHARP EDGE DUE TO THE SNAPPING OF THE HANDLE. THE PRODUCT HAD BEEN PREVIOUSLY USED WITHOUT MALFUNCTION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23786166 ↗MalfunctionNov 25, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION (T12-PELVIS) FOR SPINAL STENOSIS. PATIENT HAD MEDICAL HISTORY OF DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT TIP OF THE DRIVER WAS SHEERED OFF WHILE ATTEMPTING TO REMOVE A DOMINO CONNECTOR SET SCREW. THE SAME ISSUE OCCURRED WITH TWO INSTRUMENT 815-517 TORX 20 SHAFT DEVICES, RESULTING IN THREE TIPS BREAKING ON THE SAME SET SCREW. AFTER BREAKING THREE TIPS ON SAME SET SCREW SURGEON OPTED TO DRILL OUT THE SET SCREW AND WAS SUCCESSFUL AT REMOVING IMPLANT. TIP FRAGMENTS WERE RETRIEVED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23641978 ↗InjuryNov 4, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE BROKEN FRAGMENT REMAINS IN THE PATIENT, AND REP HAS CONFIRMED WITH THE SURGEON THAT THEY ARE NOT PLANNING TO REMOVE IT AT THIS TIME.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23462443 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
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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