Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Endosseous dental implant

Cm Titamax Ex Implant 3 5x9: medical device reports filed with FDA

227 reports name it, 2014–2019. Manufacturer given most often on reports: Neodent - Jjgc. Product code DZE.

227
device reports naming the brand
0% of all MAUDE reports · about 19 a year
0
reports, 12 months to August 2026
0 in the 12 months before
22.5%
classified as malfunction
0.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 227 reports that name the brand "Cm Titamax Ex Implant 3 5x9" (endosseous dental implant), received between November 2014 and July 2019; the manufacturer given most often on reports is Neodent - Jjgc. 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 (77.5%) and malfunction (22.5%); across all implant, endosseous, root-form reports (product code DZE) death is recorded in 0% and malfunction in 0.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to osseointegrate (92.5%), loss of osseointegration (4.4%) and difficult to remove (0.4%). The patient problems coded most often are tissue damage, pain and inadequate osseointegration. 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 Cm Titamax Ex Implant 3 5x9 was received in the five years to August 2026; the latest was received in July 2019.

By year received

0641272014: 2320142015: 2820152017: 12720172018: 4520182019: 42019

Event type and report source

Event type, as classified on the report

Death0%0
Injury77.5%176
Malfunction22.5%51
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%227
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 3,924,241 reports carrying product code DZE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to osseointegrate21092.5%62.8%
Loss of osseointegration104.4%22.4%
Difficult to removethe device was hard to remove10.4%0%
Fracturea broken bone10.4%1.6%
Insufficient device problem information10.4%0.2%

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
Tissue damage18681.9%
Painpain, site not specified3917.2%
Inadequate osseointegration2410.6%
Complaint, ill-defined125.3%
Fistula83.5%
Swellingswelling73.1%
Sinus perforation31.3%
Failure of implant10.4%

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

In context

MeasureCm Titamax Ex Implant 3 5x9Product code DZEAll MAUDE reports
Reports2273,924,24126,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports009
Classified as injury77.5%99.2%36.2%
Classified as malfunction22.5%0.8%62.3%
Filed by the manufacturer100%77.7%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 DZE

BrandReportsLatest 12 monthsClassified as death
Biohorizons Dental Implant58,73200%
BioHorizons Inc.57,02025,5360%
NobelActive Internal RP 4.3x10mm49,0989,5280%
BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim45,6509,6770%
NobelParallel CC RP 4.3x10mm44,2699,3180%
BLT ?4.1mm RC, SLActive? 10mm, TiZr, NTP41,6727,5310%
Unknown Implant39,9671,4540%
NobelReplace CC RP 4.3x10mm35,9468,1660%
NobelReplace CC PMC RP 4.3x10mm34,4478,6900%
NobelActive Internal RP 4.3x11.5mm33,1175,7040%
BLT ?3.3mm NC, SLA? 10mm, TiZr, Loxim28,6485,6950%
BLT ?4.1mm RC, SLA? 10mm, Ti, Loxim26,7248,4810%
BLT ?3.3mm NC, SLActive? 10mm, TiZr, NTP26,5404,6800%
NobelActive Internal RP 4.3x13mm25,5563,7640%
BLT ?4.1mm RC, SLA? 8mm, TiZr, Loxim24,7725,9780%

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 Cm Titamax Ex Implant 3 5x9 reports

How many FDA reports name Cm Titamax Ex Implant 3 5x9?

227 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 (77.5%) and malfunction (22.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to osseointegrate (92.5%), loss of osseointegration (4.4%), difficult to remove (0.4%), fracture (0.4%) and insufficient device problem information (0.4%). 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 Cm Titamax Ex Implant 3 5x9 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.