CAPSTONE PTC Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 21 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls
- 0
We found 21 models of CAPSTONE PTC Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2016 and Sep 30, 2026 — classified as 29 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Break” (18 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 CAPSTONE PTC Spinal System problems
Device problems
- Break18
- Migration18
- Migration or Expulsion of Device10
- Mechanics Altered3
- Use of Device Problem3
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient20
- Pain13
- No Code Available7
- Neurological Deficit/Dysfunction4
- Bone Fracture(s)2
- Unspecified Infection2
- Back pain1
CAPSTONE PTC Spinal System models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CAPSTONE PTC™ Spinal System 3992209Intervertebral fusion device with bone graft, lumbar15 reports
- CAPSTONE PTC™ Spinal System 3992210Intervertebral fusion device with bone graft, lumbar8 reports
- CAPSTONE PTC™ Spinal System 3992206Intervertebral fusion device with bone graft, lumbar6 reports
- CAPSTONE PTC™ Spinal System 3992211Intervertebral fusion device with bone graft, lumbar4 reports
- CAPSTONE PTC™ Spinal System 3992208Intervertebral fusion device with bone graft, lumbar4 reports
- CAPSTONE PTC™ Spinal System 3992612Intervertebral fusion device with bone graft, lumbar3 reports
- CAPSTONE PTC™ Spinal System 3992608Intervertebral fusion device with bone graft, lumbar3 reports
- CAPSTONE PTC™ Spinal System 3992212Intervertebral fusion device with bone graft, lumbar3 reports
- CAPSTONE PTC™ Spinal System 3992207Intervertebral fusion device with bone graft, lumbar3 reports
- CAPSTONE PTC™ Spinal System 3993209Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE PTC™ Spinal System 3992613Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE PTC™ Spinal System 3992611Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE PTC™ Spinal System 3992609Intervertebral fusion device with bone graft, lumbar2 reports
- CAPSTONE PTC™ Spinal System 3993213Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3993212Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3993211Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3993210Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3993207Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3992610Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3992214Intervertebral fusion device with bone graft, lumbar1 report
- CAPSTONE PTC™ Spinal System 3992213Intervertebral fusion device with bone graft, lumbar1 report
Recent CAPSTONE PTC Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954684 ↗MalfunctionSep 30, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954594 ↗MalfunctionSep 28, 2026Mechanical Problem; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915242 ↗MalfunctionSep 22, 2026Mechanics Altered
Information was received from the distibutor via a manufacturer representative regarding a device used for Minimally Invasive Transf oraminal Lumbar Interbody Fusion procedure. It was reported that during intra-op, the threaded connection spun freely without engaging or tightening, which prevented the cage from locking securely onto the insertion tool, and the original cage was set aside and qua rantined while a new implant was opened, which threaded and locked onto the inserter without issue.The procedure was completed successfully without patient injury. 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 50850795 ↗MalfunctionJun 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID: (B)(6), AND STUDY ID: TLIF IDE PIVOTAL - (B)(4). IT WAS REPORTED THAT DURING MMI IMAGING ANALYSIS, HARDWARE LOOSENING WAS OBSERVED. PATIENT WAS TREATED FOR 2 LEVELS. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662312 ↗MalfunctionJun 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION WAS RECEIVED FROM CLINICAL STUDY, HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), AND STUDY ID - (B)(6). IT WAS REPORTED THAT DURING MMI IMAGING ANALYSIS, HARDWARE LOOSENING WAS OBSERVED. PATIENT WAS TREATED FOR 2 LEVELS. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO REVISION SURGERY PLANNED OR SCHEDULED FOR THE REMOVAL OF IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662304 ↗MalfunctionMar 25, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINE SURGERY. IT WAS REPORTED THAT IMPLANT WAS EXPIRED. EXPIRED ON (B)(6) 2024. IMPLANT REMAINS IN PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE GRAFT WAS NOT RECEIVED FROM MEDTRONIC IN EXPIRED CONDITION, IT WAS EXPIRED IN IMPLANT SUITCASE AND WAS USER ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690311 ↗MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE EXPIRED BEFORE IT WAS SHIPPED OUT. PRODUCTS WERE USABLE AT ONE POINT THEN THEY EXPIRED. 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 21642672 ↗MalfunctionMar 19, 2025Use of Device Problem; Use of Device Problem
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANTS WERE EXPIRED BEFORE IT WAS SHIPPED OUT. PRODUCTS WERE USABLE AT ONE POINT THEN THEY EXPIRED. 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 21642654 ↗MalfunctionMar 11, 2025Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE IMPLANT WOULD NOT APPROPRIATELY THREAD ONTO THE INSERTER. IT WAS UNDETERMINED IF THE IMPLANT WAS SUFFICIENTLY CAPTURED BECAUSE IT WAS NOT SITTING FLUSH WITH THE INSERTER AND THEREFORE ANOTHER IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570930 ↗InjuryMar 11, 2025Migration; Migration
SPONSOR ASSESSMENT: CEC ADJUDICATED AS CAUSAL RELATED TO TLIF PROCEDURE, AND POSSIBLE TO TLIF GRAFTING MATERIAL, INTER BODY FUSION DEVICE, AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM.
Patient problems: Back pain; Bone Fracture(s); Intervertebral Disc Compression or Protrusion
MAUDE report 21569924 ↗MalfunctionMar 10, 2025Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR, HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH L5-S1 MIS TLIF THERAPY. IT WAS REPORTED THAT AFTER INSERTING THE CAGE SURGEON FOUND THE INSERTER INNER THREADED LOOSEN. HE SLIGHTLY IMPACTED THE INSERTER TO PUT THE CAGE DEEPER AND FOUND THE TAIL OF IMPLANT WAS BROKEN. SURGEON REMOVED ALL THE BROKEN IMPLANTS OFF AND PUT GELFOAM ON THE BROKEN SITE. HE CHECKED SEVERAL TIMES TO MAKE SURE ALL THE PARTICLE WAS REMOVED AND FINISHED THE SURGERY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21557381 ↗MalfunctionFeb 11, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF SURGERY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN WHEN THE DOCTOR WAS INSERTING THE PRODUCT. THERE IS NO FRAGMENT OF THE IMPLANT REMAINING IN THE PATIENT. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21354043 ↗MalfunctionFeb 7, 2025Failure to Align; Failure to Align
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING MINIMALLY INVASIVE TRAN SFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF). IT WAS REPORTED THAT THE INNER THREAD OF INSERTER WAS IDLE AND THE INSERTER CANNOT MOVE FORWARD AND ATTACH THE CAGE. A NEW SAME SIZE CAGE WAS OPENED AND ATTACHED SUCCESSFULLY. 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 21332011 ↗MalfunctionJan 19, 2025Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR/ HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN TLIF SURGERY FOR A LUMBAR HIVD. IT WAS REPORTED THAT WHEN THE SURGEON IMPLANTED THE CAGE FULLY AND TRIED TO IMPACT THE CAGE DEEPER, THE TAIL OF CAGE WAS BROKEN. THE FRAGMENTS OF THE CAGE WERE REMOVED AND THE OPERATION WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21187829 ↗
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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