Device brand name · Plate cranioplasty preformed alterable
Ti Matrixneuro Screw Self-Drilling 4mm: medical device reports filed with FDA
758 reports name it, 2011–2026. Manufacturer given most often on reports: Synthes. Product code JEY.
- 758
- device reports naming the brand
- 0% of all MAUDE reports · about 51 a year
- 74
- reports, 12 months to August 2026
- 127 in the 12 months before
- 60%
- classified as malfunction
- 48.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
758 medical device reports received by FDA name the brand "Ti Matrixneuro Screw Self-Drilling 4mm" (plate cranioplasty preformed alterable); the manufacturer given most often on reports is Synthes; received from October 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
74 reports arrived in the 12 months to August 2026, down 42% from 127 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 malfunction (60%) and injury (40%); across all plate, bone reports (product code JEY) death is recorded in 0.2% and malfunction in 48.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (46%), insufficient device problem information (9.4%) and device-device incompatibility (3.2%). The patient problems coded most often are post operative wound infection, cerebrospinal fluid leakage and tissue 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 10,487 reports carrying product code JEY. 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 | 349 | 46% | 35.7% |
| Insufficient device problem information | 71 | 9.4% | 5.3% |
| Device-device incompatibility | 24 | 3.2% | 2.1% |
| Material twisted/bent | 23 | 3% | 1.8% |
| Material fragmentation | 20 | 2.6% | 1% |
| Failure to cut | 18 | 2.4% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 1.8% | 1.5% |
| Difficult to advance | 11 | 1.5% | 0.4% |
| Crackthe device cracked | 10 | 1.3% | 0.6% |
| Entrapment of device | 10 | 1.3% | 0.7% |
| Nonstandard device | 10 | 1.3% | 0.3% |
| Device contaminated during manufacture or shipping | 9 | 1.2% | 0.7% |
| Detachment of device component | 7 | 0.9% | 2.3% |
| Manufacturing, packaging or shipping problem | 6 | 0.8% | 1.5% |
| Material deformation | 6 | 0.8% | 7.1% |
| Difficult to insertthe device was hard to insert | 5 | 0.7% | 1.1% |
| Dull, blunt | 5 | 0.7% | 0.2% |
| Component falling | 3 | 0.4% | 0.2% |
| Component missing | 2 | 0.3% | 0.1% |
| Detachment of device or device componentpart of the device came off | 2 | 0.3% | 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 |
|---|---|---|
| Post operative wound infection | 33 | 4.4% |
| Cerebrospinal fluid leakage | 30 | 4% |
| Tissue damage | 29 | 3.8% |
| Device embedded in tissue or plaque | 19 | 2.5% |
| Foreign body in patientpart of a device left in the patient | 14 | 1.8% |
| Reactiona reaction, type not specified | 14 | 1.8% |
| Painpain, site not specified | 9 | 1.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 8 | 1.1% |
| Not applicable | 7 | 0.9% |
| Discharge | 5 | 0.7% |
| Failure of implant | 2 | 0.3% |
| No patient involvement | 2 | 0.3% |
| Bone fracture(s) | 1 | 0.1% |
| Hypersensitivity/allergic reaction | 1 | 0.1% |
| Infection, pyrogenic | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ti Matrixneuro Screw Self-Drilling 4mm | Product code JEY | All MAUDE reports |
|---|---|---|---|
| Reports | 758 | 10,487 | 26,136,888 |
| Share of that pool | — | 7.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 40% | 49.8% | 36.2% |
| Classified as malfunction | 60% | 48.8% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.3% | 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 JEY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cmf | 431 | 431 | 0% |
| Ti Low Profile Neuro Screw Self-Drilling 4mm | 430 | 4 | 0% |
| 2 0mm Rapid Resorbable Cortex Screw 4mm-Sterile | 346 | 107 | 0% |
| 1 5mm Rapid Resorbable Cortex Screw 6mm | 226 | 165 | 0% |
| Level One Cmf | 546 | 32 | 0% |
| Biomet Microfixation Facial Plating System | 193 | 0 | 0% |
| 1 85mm Ti Matrix Screw Self-Tapping/6mm | 170 | 16 | 0% |
| UNK - Screws: CMF | 410 | 280 | 0% |
| Matneu Scr 1 5 Self-Drill L4 Tan 4u I/C | 180 | 41 | 0% |
| Ti Matrixneuro Screw Self-Drilling 5mm | 184 | 50 | 0% |
| Cranial-Scr PlusDrive 1.6 self-drill L4 | 165 | 8 | 0% |
| Unknown_Fro_Product | 192 | 7 | 0% |
| Matneu Scr 1 5 Self-Drill L4 Tan 1u I/C | 226 | 62 | 0% |
| UNK - Screws: Locking | 2,331 | 98 | 0% |
| Unk - Screws Cortex | 889 | 16 | 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 Matrixneuro Screw Self-Drilling 4mm reports
How many FDA reports name Ti Matrixneuro Screw Self-Drilling 4mm?
758 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 74 in the latest 12 months.
What kinds of events are reported?
malfunction (60%) and injury (40%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (46%), insufficient device problem information (9.4%), device-device incompatibility (3.2%), material twisted/bent (3%) and material fragmentation (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ti Matrixneuro Screw Self-Drilling 4mm 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.