Devices › Intervertebral fusion device with bone graft, lumbar
Device brand name · Intervertebral fusion device with bone graft lumbar
CAPSTONE Spinal System: medical device reports filed with FDA
358 reports name it, 2009–2026. Manufacturer given most often on reports: Mdt Sofamor Danek Puerto Rico Mfg. Product code MAX.
- 358
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 26
- reports, 12 months to August 2026
- 17 in the 12 months before
- 46.1%
- classified as malfunction
- 63.3% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
358 medical device reports received by FDA name the brand "CAPSTONE Spinal System" (intervertebral fusion device with bone graft lumbar); the manufacturer given most often on reports is Mdt Sofamor Danek Puerto Rico Mfg; received from September 2009 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
26 reports arrived in the 12 months to August 2026, up 53% from 17 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (51.4%), malfunction (46.1%) and death (0.3%); across all intervertebral fusion device with bone graft, lumbar reports (product code MAX) death is recorded in 0.3% and malfunction in 63.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (31%), migration or expulsion of device (18.4%) and device dislodged or dislocated (2%). The patient problems coded most often are pain, erosion and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 9,238 reports carrying product code MAX. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 111 | 31% | 28.7% |
| Migration or expulsion of device | 66 | 18.4% | 6.8% |
| Device dislodged or dislocated | 7 | 2% | 2.1% |
| Migrationthe device moved from where it was placed | 7 | 2% | 8.5% |
| Fracturea broken bone | 6 | 1.7% | 8.5% |
| Crackthe device cracked | 5 | 1.4% | 1.4% |
| Malposition of device | 5 | 1.4% | 1.3% |
| Insufficient device problem information | 4 | 1.1% | 2% |
| Loosening of implant not related to bone-ingrowth | 4 | 1.1% | 0.3% |
| Mechanical problema mechanical problem | 4 | 1.1% | 5.7% |
| Detachment of device component | 3 | 0.8% | 1.4% |
| Device slipped | 3 | 0.8% | 0.8% |
| Detachment of device or device componentpart of the device came off | 2 | 0.6% | 1.1% |
| Difficult to position | 2 | 0.6% | 0.3% |
| Accessory incompatible | 1 | 0.3% | 0% |
| Bent | 1 | 0.3% | 0.4% |
| Degraded | 1 | 0.3% | 0% |
| Device contamination with chemical or other material | 1 | 0.3% | 0% |
| Disconnection | 1 | 0.3% | 0.1% |
| Fitting problem | 1 | 0.3% | 0.7% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 49 | 13.7% |
| Erosion | 44 | 12.3% |
| Device embedded in tissue or plaque | 19 | 5.3% |
| Neurological deficit/dysfunction | 10 | 2.8% |
| Neuropathy | 7 | 2% |
| Injurya physical injury | 4 | 1.1% |
| Post operative wound infection | 4 | 1.1% |
| Stenosis | 4 | 1.1% |
| Bone fracture(s) | 3 | 0.8% |
| Discomfortdiscomfort | 3 | 0.8% |
| Failure of implant | 3 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.6% |
| Falla fall | 2 | 0.6% |
| Fever | 2 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CAPSTONE Spinal System | Product code MAX | All MAUDE reports |
|---|---|---|---|
| Reports | 358 | 9,238 | 26,136,888 |
| Share of that pool | — | 3.9% | 0% |
| Classified as death, per 1,000 reports | 3 | 3 | 9 |
| Classified as injury | 51.4% | 35.6% | 36.2% |
| Classified as malfunction | 46.1% | 63.3% | 62.3% |
| Filed by the manufacturer | 99.2% | 97.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MAX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Catalyft PL Expandable Interbody System | 378 | 95 | 0% |
| ELEVATE Spinal System | 386 | 46 | 0% |
| Crescent Spinal System | 322 | 5 | 0.6% |
| Clydesdale Spinal System | 260 | 33 | 0.4% |
| CLYDESDALE PTC Spinal System | 222 | 5 | 0% |
| Pivox Oblique Lateral Spinal System | 255 | 5 | 0% |
| T-Pal Spacer Applicator Inner Shaft | 271 | 0 | 0% |
| T-Pal Spacer Applicator Knob | 185 | 0 | 0% |
| T-Pal Spacer Applicator Handle | 157 | 0 | 0% |
| Unknown Cage/Spacer | 280 | 4 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Orthopedic Manual Surgical Instrument | 1,143 | 0 | 0.2% |
| Collect No Qas Spine Anterior Stabilis | 269 | 0 | 0% |
| Verte-Stack Spinal System | 212 | 0 | 0.5% |
| Divergence Anterior Cervical Fusion System | 230 | 30 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about CAPSTONE Spinal System reports
How many FDA reports name CAPSTONE Spinal System?
358 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 26 in the latest 12 months.
What kinds of events are reported?
injury (51.4%), malfunction (46.1%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (31%), migration or expulsion of device (18.4%), device dislodged or dislocated (2%), migration (2%) and fracture (1.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CAPSTONE Spinal System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.