ENDOSKELETON TCSRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 12 models of ENDOSKELETON TCS by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Sep 25, 2017 and Jun 9, 2026 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Break” (16 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 ENDOSKELETON TCS problems
Device problems
- Break16
- Manufacturing, Packaging or Shipping Problem2
- Mechanical Problem2
- Component Falling1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient8
- No Patient Involvement1
ENDOSKELETON TCS models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOSKELETON® TCS 5302-3514Intervertebral fusion device with integrated fixation, cervical5 reports
- ENDOSKELETON® TCS 5210-1067-25ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- ENDOSKELETON® TCS 5210-1067-15ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- ENDOSKELETON® TCS 5366-1410Intervertebral fusion device with integrated fixation, cervical2 reports
- ENDOSKELETON® TCS 5302-3516Intervertebral fusion device with integrated fixation, cervical2 reports
- ENDOSKELETON® TCS 5210-1004SCREWDRIVER2 reports
- ENDOSKELETON® TCS 5210-1021DRIVER, PROSTHESIS2 reports
- ENDOSKELETON® TCS 5301-3514Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5301-3516Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5301-3814Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5302-3518Intervertebral fusion device with integrated fixation, cervical1 report
- ENDOSKELETON® TCS 5210-1067-90ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent ENDOSKELETON TCS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A ACDF PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOSIS. IT WAS REPORTED THAT THE STAPLE HEAD LOCKING RING WAS BROKEN AND LOCKING FAILED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. UPDATE RECEIVED ON 22 JUL 2025: EVENT DID NOT OCCUR DUE TO USER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443026 ↗MalfunctionMay 18, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR ANTERIOR CER VICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE TIP OF THE INSERTER WAS NO LONGER HOLDING THE IMPLANT SECURELY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199542 ↗MalfunctionApr 21, 2026Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DRIVER HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE. IT WAS REPORTED THAT THE BUR CAME INTO CONTACT WITH A TISSUE RETRACTION BLADE AND BROKE INSIDE THE INSTRUMENT. IT WAS REPORTED THAT NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934178 ↗MalfunctionOct 12, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A ACDF PROCEDURE IN A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOSIS. IT WAS REPORTED THAT THE STAPLE HEAD LOCKING RING WAS BROKEN AND LOCKING FAILED. EVENT DID NOT OCCUR DUE TO USER ISSUE. 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 23274314 ↗MalfunctionJul 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE WRONG IMPLANT WERE SENT IN THE CORRECT PACKAGED, ORDERED TCS CERVICAL AND GOT LUMBAR ALIF CAGES. THERE WERE NO PATIENT SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22410231 ↗MalfunctionJul 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE WRONG IMPLANT WERE SENT IN THE CORRECT PACKAGED, ORDERED TCS CERVICAL AND GOT LUMBAR ALIF CAGES. THERE WERE NO PATIENT SYMPTOMS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22410220 ↗MalfunctionJun 23, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR C6-7 ANTERIOR CERVICAL FUS ION. IT WAS REPORTED THAT THE TIP OF THE DRIVER IS BROKEN OFF. IT WAS NOTICED WHILE ASSEMBLING THE INSTRUMENTS FOR SURGERY AND IT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22305311 ↗MalfunctionMar 14, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT SCREWDRIVERS HAVE WORN DOWN AND BROKEN OVER TIME. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605349 ↗MalfunctionMar 14, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT SCREWDRIVERS HAVE WORN DOWN AND BROKEN OVER TIME. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605315 ↗MalfunctionFeb 9, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVERS AND HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21340945 ↗MalfunctionFeb 9, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE DRIVERS AND HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21340944 ↗MalfunctionFeb 4, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR ACDF THERAPY. IT WAS REPORTED THAT THE MECHANISM INTERFACE WAS STRIPPED, UNABLE TO TURN DRIVER. DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21302089 ↗MalfunctionJan 30, 2025Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, FRIEND/FAMILY MEMBER) REGARDING A PATIENT HAVING PRE-OPERATIVE DIAGNOSIS FOR STENOSIS. PROCEDURE OR TECHNIQUE USED WAS ACDF. LEVELS IMPLANTED C3-4. IT WAS REPORTED THAT WHILE USING THIS DRIVER THE TIP CRACKED. IT COULD NO LONGER BE USED. THE SMALL DRIVER BIT WAS BROKEN AT THE END OF THE CASE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR NEGATIVE CONSEQUENCES TO THE PATIENT. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE PRODUCT DID NOT COME INTO CONTACT WITH THE PATIENT. WHEN LOADING A SCREW, IT WAS DISCOVERED IT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273122 ↗MalfunctionJan 30, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C5-7 ANTERIOR C ERVICAL DISCECTOMY AND FUSION (ACDF) FOR AN INDICATION OF CENTRAL STENOSIS. IT WAS REPORTED THAT THE TIP OF DRIVER BROKE OFF INTO THE HEAD OF THE SCREW WHILE THE SCREW WAS BEING IMPLANTED. 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 21271483 ↗MalfunctionJan 18, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING THE INSTRUMENTS USED FOR ACDF THERAPY. IT WAS REPORTED THAT THE MECHANISM INTERFACE WAS STRIPPED, UNABLE TO TURN DRIVER. DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21186459 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 16 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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