Devices › Thoracolumbosacral pedicle screw system
Device brand name · Matrix locking cap
Ti Matrix Locking Cap: medical device reports filed with FDA
489 reports name it, 2011–2021. Manufacturer given most often on reports: Synthes Brandywine. Product code NKB.
- 489
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 15.3%
- classified as malfunction
- 41.2% across the product code
- 1.2%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 489 reports that name the brand "Ti Matrix Locking Cap" (matrix locking cap), received between March 2011 and April 2021; the manufacturer given most often on reports is Synthes Brandywine. Spellings of one product vary from report to report.
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 (83.4%), malfunction (15.3%) and death (1.2%); 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 device slipped (20.2%), break (16.2%) and device dislodged or dislocated (13.7%). The patient problems coded most often are pain, failure of implant and nonunion/delayed-union bone fracture. 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 Matrix Locking Cap was received in the five years to August 2026; the latest was received in April 2021.
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 |
|---|---|---|---|
| Device slipped | 99 | 20.2% | 6% |
| Breakthe device broke | 79 | 16.2% | 21.4% |
| Device dislodged or dislocated | 67 | 13.7% | 4.4% |
| Difficult to removethe device was hard to remove | 57 | 11.7% | 1.3% |
| Detachment of device component | 49 | 10% | 2.8% |
| Migration or expulsion of device | 41 | 8.4% | 4.6% |
| Insufficient device problem information | 37 | 7.6% | 3.2% |
| Loose or intermittent connection | 33 | 6.7% | 4.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 23 | 4.7% | 2.3% |
| Malposition of device | 22 | 4.5% | 1.1% |
| Sticking | 12 | 2.5% | 0.3% |
| Naturally worn | 10 | 2% | 0.2% |
| Fitting problem | 9 | 1.8% | 0.4% |
| Positioning problem | 8 | 1.6% | 0.5% |
| Unintended collision | 8 | 1.6% | 0% |
| Unstable | 8 | 1.6% | 0.2% |
| Fracturea broken bone | 7 | 1.4% | 8.1% |
| Material fragmentation | 6 | 1.2% | 0.8% |
| Connection problema connection problem | 5 | 1% | 0.2% |
| Mechanical jam | 5 | 1% | 0.6% |
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 | 88 | 18% |
| Failure of implant | 29 | 5.9% |
| Nonunion/delayed-union bone fracture | 23 | 4.7% |
| Bone fracture(s) | 18 | 3.7% |
| Post operative wound infection | 14 | 2.9% |
| Impaired healingslow healing | 13 | 2.7% |
| Sedationdrowsiness from a medicine | 9 | 1.8% |
| Numbnessnumbness | 8 | 1.6% |
| Stenosis | 7 | 1.4% |
| Tissue damage | 7 | 1.4% |
| Deaththe patient died; cause not stated by this term | 6 | 1.2% |
| Device embedded in tissue or plaque | 6 | 1.2% |
| Complaint, ill-defined | 5 | 1% |
| Falla fall | 5 | 1% |
| Vascular system (circulation), impaired | 4 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ti Matrix Locking Cap | Product code NKB | All MAUDE reports |
|---|---|---|---|
| Reports | 489 | 24,738 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 12 | 3 | 9 |
| Classified as injury | 83.4% | 58.1% | 36.2% |
| Classified as malfunction | 15.3% | 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% |
| 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% |
| 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 Ti Matrix Locking Cap reports
How many FDA reports name Ti Matrix Locking Cap?
489 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 (83.4%), malfunction (15.3%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device slipped (20.2%), break (16.2%), device dislodged or dislocated (13.7%), difficult to remove (11.7%) and detachment of device component (10%). 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 Matrix Locking Cap 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.