Reported Reactions

Devices › Plate, bone

Device brand name · Plate cranioplasty preformed alterable

Ti Matrixneuro Screw Self-Drilling 5mm: medical device reports filed with FDA

184 reports name it, 2013–2026. Manufacturer given most often on reports: Synthes USA. Product code JEY.

184
device reports naming the brand
0% of all MAUDE reports · about 14 a year
50
reports, 12 months to August 2026
3 in the 12 months before
79.3%
classified as malfunction
48.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 184 reports that name the brand "Ti Matrixneuro Screw Self-Drilling 5mm" (plate cranioplasty preformed alterable), received between March 2013 and August 2026; the manufacturer given most often on reports is Synthes USA. Spellings of one product vary from report to report.

50 reports arrived in the 12 months to August 2026, up 1567% from 3 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 (79.3%) and injury (20.7%); 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 (63.6%), detachment of device or device component (3.8%) and entrapment of device (3.8%). The patient problems coded most often are hematoma, device embedded in tissue or plaque and foreign body in patient. 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

01938Sep 2021: 5Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 2Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 2Oct 2022: 1Nov 2022: 1Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 5Apr 2024: 4May 2024: 3Jun 2024: 0Jul 2024: 1Aug 2024: 0Sep 2024: 2Oct 2024: 1Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 2Feb 2026: 38Mar 2026: 1Apr 2026: 1May 2026: 0Jun 2026: 3Jul 2026: 4Aug 2026: 1

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

025502013: 1820132014: 102015: 2420152016: 82017: 2920172018: 132020: 520202021: 52022: 620222024: 162026: 502026

Event type and report source

Event type, as classified on the report

Death0%0
Injury20.7%38
Malfunction79.3%146
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%184
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Breakthe device broke11763.6%35.7%
Detachment of device or device componentpart of the device came off73.8%0.6%
Entrapment of device73.8%0.7%
Material twisted/bent63.3%1.8%
Material fragmentation52.7%1%
Detachment of device component42.2%2.3%
Component falling31.6%0.2%
Difficult to insertthe device was hard to insert31.6%1.1%
Device or device fragments location unknown10.5%0.1%
Inadequacy of device shape and/or size10.5%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)ReportsShare
Hematomaa collection of blood under the skin or in tissue1910.3%
Device embedded in tissue or plaque126.5%
Foreign body in patientpart of a device left in the patient94.9%
Hemorrhage/blood loss/bleeding31.6%
No patient involvement31.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureTi Matrixneuro Screw Self-Drilling 5mmProduct code JEYAll MAUDE reports
Reports18410,48726,136,888
Share of that pool—1.8%0%
Classified as death, per 1,000 reports029
Classified as injury20.7%49.8%36.2%
Classified as malfunction79.3%48.8%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Ti Matrixneuro Screw Self-Drilling 4mm758740%
Cmf4314310%
Ti Low Profile Neuro Screw Self-Drilling 4mm43040%
2 0mm Rapid Resorbable Cortex Screw 4mm-Sterile3461070%
1 5mm Rapid Resorbable Cortex Screw 6mm2261650%
Level One Cmf546320%
Biomet Microfixation Facial Plating System19300%
1 85mm Ti Matrix Screw Self-Tapping/6mm170160%
UNK - Screws: CMF4102800%
Matneu Scr 1 5 Self-Drill L4 Tan 4u I/C180410%
Cranial-Scr PlusDrive 1.6 self-drill L416580%
Unknown_Fro_Product19270%
Matneu Scr 1 5 Self-Drill L4 Tan 1u I/C226620%
UNK - Screws: Locking2,331980%
Unk - Screws Cortex889160%

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 5mm reports

How many FDA reports name Ti Matrixneuro Screw Self-Drilling 5mm?

184 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.

What kinds of events are reported?

malfunction (79.3%) and injury (20.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (63.6%), detachment of device or device component (3.8%), entrapment of device (3.8%), material twisted/bent (3.3%) and material fragmentation (2.7%). 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 Matrixneuro Screw Self-Drilling 5mm 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.