Devices › Thoracolumbosacral pedicle screw system
Device brand name · Orthosis spinal pedicle fixation for ddd
Ti 12-Point Nut-11mm: medical device reports filed with FDA
174 reports name it, 2012–2019. Manufacturer given most often on reports: Synthes USA. Product code NKB.
- 174
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 18.4%
- classified as malfunction
- 41.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
174 medical device reports received by FDA name the brand "Ti 12-Point Nut-11mm" (orthosis spinal pedicle fixation for ddd); the manufacturer given most often on reports is Synthes USA; received from March 2012 to December 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (81.6%) and malfunction (18.4%); 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 migration or expulsion of device (15.5%), break (13.8%) and device slipped (9.2%). The patient problems coded most often are pain, impaired healing and failure of implant. 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
No report naming Ti 12-Point Nut-11mm was received in the five years to August 2026; the latest was received in December 2019.
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 |
|---|---|---|---|
| Migration or expulsion of device | 27 | 15.5% | 4.6% |
| Breakthe device broke | 24 | 13.8% | 21.4% |
| Device slipped | 16 | 9.2% | 6% |
| Bent | 12 | 6.9% | 0.4% |
| Connection problema connection problem | 10 | 5.7% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 4.6% | 2.3% |
| Mechanical jam | 8 | 4.6% | 0.6% |
| Fitting problem | 6 | 3.4% | 0.4% |
| Insufficient device problem information | 6 | 3.4% | 3.2% |
| Loose or intermittent connection | 6 | 3.4% | 4.6% |
| Device dislodged or dislocated | 5 | 2.9% | 4.4% |
| Fracturea broken bone | 5 | 2.9% | 8.1% |
| Difficult to insertthe device was hard to insert | 4 | 2.3% | 0.4% |
| Difficult to position | 3 | 1.7% | 0.1% |
| Failure to align | 3 | 1.7% | 0.6% |
| Failure to adhere or bond | 2 | 1.1% | 0.3% |
| Material deformation | 2 | 1.1% | 5.5% |
| Crackthe device cracked | 1 | 0.6% | 0.4% |
| Detachment of device component | 1 | 0.6% | 2.8% |
| Unintended movement | 1 | 0.6% | 1.5% |
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 | 63 | 36.2% |
| Impaired healingslow healing | 28 | 16.1% |
| Failure of implant | 19 | 10.9% |
| Nonunion/delayed-union bone fracture | 14 | 8% |
| Nerve damage | 13 | 7.5% |
| Limited mobility of the implanted joint | 9 | 5.2% |
| Falla fall | 8 | 4.6% |
| Weakness | 8 | 4.6% |
| Stenosis | 6 | 3.4% |
| Bone fracture(s) | 4 | 2.3% |
| Neurological deficit/dysfunction | 4 | 2.3% |
| Inflammationinflammation | 3 | 1.7% |
| Injurya physical injury | 3 | 1.7% |
| Spinal column injury | 3 | 1.7% |
| Device embedded in tissue or plaque | 2 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ti 12-Point Nut-11mm | Product code NKB | All MAUDE reports |
|---|---|---|---|
| Reports | 174 | 24,738 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 81.6% | 58.1% | 36.2% |
| Classified as malfunction | 18.4% | 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% |
| Unknown_Spine_Product | 596 | 24 | 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 Ti 12-Point Nut-11mm reports
How many FDA reports name Ti 12-Point Nut-11mm?
174 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (81.6%) and malfunction (18.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (15.5%), break (13.8%), device slipped (9.2%), bent (6.9%) and connection problem (5.7%). 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 Ti 12-Point Nut-11mm 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.