Plate, bone: medical device reports filed with FDA

10,487 reports carry this product code, 1992–2026; 20 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

10,487
reports with this product code: 0% of all MAUDE reports; 1,566
reports, 12 months to August 2026: 920 in the 12 months before; 48.8%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code JEY is FDA's classification for "Plate, bone" (dental panel), a class 2 device. 10,487 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

1,566 reports arrived in the 12 months to August 2026, up 70% from 920 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 (49.8%), malfunction (48.8%) and other (1%). 20 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Ti Matrixneuro Screw Self-Drilling 4mm	436	74	0%	60%
Cmf	430	431	0%	99.8%
Ti Low Profile Neuro Screw Self-Drilling 4mm	424	4	0%	71.9%
2 0mm Rapid Resorbable Cortex Screw 4mm-Sterile	346	107	0%	95.4%
1 5mm Rapid Resorbable Cortex Screw 6mm	226	165	0%	100%
Level One Cmf	206	32	0%	2%
Biomet Microfixation Facial Plating System	181	0	0%	18.7%
1 85mm Ti Matrix Screw Self-Tapping/6mm	135	16	0%	34.1%
UNK - Screws: CMF	128	280	0%	76.1%
Matneu Scr 1 5 Self-Drill L4 Tan 4u I/C	115	41	0%	95%
Ti Matrixneuro Screw Self-Drilling 5mm	104	50	0%	79.3%
Cranial-Scr PlusDrive 1.6 self-drill L4	100	8	0%	95.2%
Unknown_Fro_Product	87	7	0%	36.5%
Matneu Scr 1 5 Self-Drill L4 Tan 1u I/C	26	62	0%	97.3%
UNK - Screws: Locking	21	98	0%	14.3%
Unk - Screws Cortex	12	16	0%	3.4%
UNK - Screws: Trauma	5	288	0%	16.6%
Distraction	4	13	0%	6.6%
Unk - Plates	2	0	0%	5.5%
Synthes	1	0	0.6%	36.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Synthes	2,459	23.4%
Biomet Microfixation	1,789	17.1%
Synthes USA	1,294	12.3%
Stryker Leibinger Freiburg	645	6.2%
Oberdorf Synthes Produktions	607	5.8%
Synthes Monument	429	4.1%
Stryker Osteosynthesis Freiburg	364	3.5%
Karl Leibinger Medizintechnik & Kg	281	2.7%
Wrights Lane Synthes USA Products	152	1.4%
Medtronic Neurosurgery	121	1.2%
Synthes Elmira	119	1.1%
Synthes Bettlach	49	0.5%
Synthes Oberdorf	34	0.3%
Synthes Selzach	21	0.2%
Synthes Brandywine	15	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.2%21

Injury49.8%5,223

Malfunction48.8%5,122

Other1%105

Not given0.2%16

Who filed

Manufacturer report99.3%10,410

Voluntary report0.3%34

User facility report0%0

Distributor report0%3

Not given0.4%40

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	3,748	35.7%
Fracturea broken bone	878	8.4%
Material deformation	746	7.1%
Insufficient device problem information	551	5.3%
Device slipped	266	2.5%
Detachment of device component	241	2.3%
Device-device incompatibility	215	2.1%
Material twisted/bent	191	1.8%
Manufacturing, packaging or shipping problem	161	1.5%
Device operates differently than expectedthe device behaved unexpectedly	156	1.5%
Explanted	132	1.3%
Migration or expulsion of device	122	1.2%
Difficult to insertthe device was hard to insert	117	1.1%
Migrationthe device moved from where it was placed	117	1.1%
Device dislodged or dislocated	107	1%
Material fragmentation	105	1%
Unintended movement	82	0.8%
Entrapment of device	78	0.7%
Inadequacy of device shape and/or size	77	0.7%
Loose or intermittent connection	75	0.7%

Questions about plate, bone reports

What is product code JEY?

FDA's classification code for "Plate, bone", class 2, reviewed by the dental panel. Every device report carries the product code of the device involved.

How many reports carry this code?

10,487 reports through August 2026, 1,566 of them in the latest 12 months.

Which brands appear most often?

Ti Matrixneuro Screw Self-Drilling 4mm (436), Cmf (430), Ti Low Profile Neuro Screw Self-Drilling 4mm (424), 2 0mm Rapid Resorbable Cortex Screw 4mm-Sterile (346) and 1 5mm Rapid Resorbable Cortex Screw 6mm (226). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.