Devices › Thoracolumbosacral pedicle screw system
Device brand name · Thoracolumbosacral pedicle screw system
Unknown_Spine_Product: medical device reports filed with FDA
596 reports name it, 2013–2026. Manufacturer given most often on reports: Stryker Spine-US. Product code NKB.
- 596
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 24
- reports, 12 months to August 2026
- 63 in the 12 months before
- 34.4%
- classified as malfunction
- 41.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 596 reports that name the brand "Unknown_Spine_Product" (thoracolumbosacral pedicle screw system), received between January 2013 and March 2026; the manufacturer given most often on reports is Stryker Spine-US. Spellings of one product vary from report to report.
24 reports arrived in the 12 months to August 2026, down 62% from 63 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 (65.6%) and malfunction (34.4%); across all thoracolumbosacral pedicle screw system reports (product code NKB) death is recorded in 0.3% and malfunction in 41.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (21.3%), fracture (21.1%) and insufficient device problem information (20.1%). The patient problems coded most often are pain, injury and nerve damage. 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 24,738 reports carrying product code NKB. 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 | 127 | 21.3% | 21.4% |
| Fracturea broken bone | 126 | 21.1% | 8.1% |
| Insufficient device problem information | 120 | 20.1% | 3.2% |
| Migrationthe device moved from where it was placed | 113 | 19% | 6.1% |
| Device dislodged or dislocated | 48 | 8.1% | 4.4% |
| Loose or intermittent connection | 24 | 4% | 4.6% |
| Mechanical problema mechanical problem | 24 | 4% | 1.6% |
| Material integrity problema problem with the device material | 22 | 3.7% | 0.6% |
| Migration or expulsion of device | 22 | 3.7% | 4.6% |
| Detachment of device component | 21 | 3.5% | 2.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 21 | 3.5% | 2.3% |
| Malposition of device | 16 | 2.7% | 1.1% |
| Device slipped | 14 | 2.3% | 6% |
| Detachment of device or device componentpart of the device came off | 10 | 1.7% | 2.8% |
| Unintended movement | 9 | 1.5% | 1.5% |
| Bent | 8 | 1.3% | 0.4% |
| Noise, audible | 8 | 1.3% | 0.2% |
| Positioning problem | 8 | 1.3% | 0.5% |
| Improper or incorrect procedure or method | 7 | 1.2% | 0.4% |
| Collapse | 5 | 0.8% | 0% |
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 | 108 | 18.1% |
| Injurya physical injury | 102 | 17.1% |
| Nerve damage | 20 | 3.4% |
| Spinal cord injury | 20 | 3.4% |
| Vertebral fracture | 15 | 2.5% |
| Neck painneck pain | 12 | 2% |
| Failure of implant | 9 | 1.5% |
| Spinal column injury | 8 | 1.3% |
| Discomfortdiscomfort | 7 | 1.2% |
| Bone fracture(s) | 5 | 0.8% |
| Hypersensitivity/allergic reaction | 5 | 0.8% |
| Movement disorder | 5 | 0.8% |
| Reactiona reaction, type not specified | 5 | 0.8% |
| Urinary incontinenceleaking urine | 5 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown_Spine_Product | Product code NKB | All MAUDE reports |
|---|---|---|---|
| Reports | 596 | 24,738 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 65.6% | 58.1% | 36.2% |
| Classified as malfunction | 34.4% | 41.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 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 NKB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CD HORIZON Spinal System | 9,787 | 634 | 0.3% |
| Ti Matrix Locking Cap | 489 | 0 | 1.2% |
| Blocker | 456 | 0 | 0% |
| Nuvasive Reline System | 468 | 8 | 1.5% |
| Single-Inner Setscrew | 454 | 19 | 0% |
| Closure Top | 440 | 27 | 0% |
| CD HORIZON SOLERA VOYAGER Spinal System | 775 | 216 | 0.1% |
| 5 5 Exp Verse Unitized Set Scr | 309 | 11 | 0% |
| Open Implant Closure Top | 277 | 0 | 0% |
| Unknown Mono/Polyaxial Screws | 390 | 0 | 0% |
| CD HORIZON SOLERA Spinal System | 320 | 68 | 0% |
| Verse Correction Key | 288 | 3 | 0% |
| Xia 3 Titanium Blocker | 340 | 7 | 0% |
| Mis Single Inner Setscw | 209 | 9 | 0.5% |
| Ti 12-Point Nut-11mm | 174 | 0 | 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 Unknown_Spine_Product reports
How many FDA reports name Unknown_Spine_Product?
596 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.
What kinds of events are reported?
injury (65.6%) and malfunction (34.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (21.3%), fracture (21.1%), insufficient device problem information (20.1%), migration (19%) and device dislodged or dislocated (8.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown_Spine_Product 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.