Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Dynamic implant sp 4 2x10

Dymic: medical device reports filed with FDA

6,189 reports name it, 2020–2026. Manufacturer given most often on reports: Paltop Advanced Dental Solutions. Product code DZE.

6,189
device reports naming the brand
0% of all MAUDE reports · about 953 a year
660
reports, 12 months to August 2026
2,404 in the 12 months before
0%
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 6,189 reports that name the brand "Dymic" (dynamic implant sp 4 2x10), received between January 2020 and August 2026; the manufacturer given most often on reports is Paltop Advanced Dental Solutions. Spellings of one product vary from report to report.

660 reports arrived in the 12 months to August 2026, down 73% from 2,404 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 (100%); 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 (92.9%), loss of osseointegration (6.8%) and failure to disconnect (0.1%). The patient problems coded most often are inadequate osseointegration, failure of implant and implant pain. 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

0247493Sep 2021: 55Oct 2021: 68Nov 2021: 46Dec 2021: 412022Jan 2022: 98Feb 2022: 101Mar 2022: 139Apr 2022: 90May 2022: 85Jun 2022: 63Jul 2022: 52Aug 2022: 88Sep 2022: 69Oct 2022: 33Nov 2022: 55Dec 2022: 2752023Jan 2023: 143Feb 2023: 201Mar 2023: 24Apr 2023: 28May 2023: 38Jun 2023: 18Jul 2023: 43Aug 2023: 54Sep 2023: 44Oct 2023: 169Nov 2023: 98Dec 2023: 592024Jan 2024: 76Feb 2024: 66Mar 2024: 35Apr 2024: 84May 2024: 62Jun 2024: 62Jul 2024: 79Aug 2024: 61Sep 2024: 99Oct 2024: 118Nov 2024: 241Dec 2024: 4932025Jan 2025: 318Feb 2025: 289Mar 2025: 364Apr 2025: 164May 2025: 134Jun 2025: 80Jul 2025: 70Aug 2025: 34Sep 2025: 54Oct 2025: 85Nov 2025: 40Dec 2025: 202026Jan 2026: 43Feb 2026: 43Mar 2026: 66Apr 2026: 49May 2026: 94Jun 2026: 109Jul 2026: 37Aug 2026: 20

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

08261,6522020: 11620202021: 41720212022: 1,14820222023: 91920232024: 1,47620242025: 1,65220252026: 4612026

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%6,189
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%6,189
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 osseointegrate5,74892.9%62.8%
Loss of osseointegration4236.8%22.4%
Failure to disconnect80.1%0%
Fracturea broken bone50.1%1.6%
Failure to align10%0%
Fitting problem10%0%
Loosening of implant not related to bone-ingrowth10%0.1%
Osseointegration problem10%7.7%

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
Inadequate osseointegration2,00932.5%
Failure of implant1,02216.5%
Implant pain4927.9%
Osteopenia/ osteoporosis3916.3%
Painpain, site not specified2393.9%
Bacterial infectiona bacterial infection981.6%
High blood pressure/ hypertension911.5%
Bruxism701.1%
Osteolysis661.1%
Foreign body reaction160.3%
Bone fracture(s)60.1%
Inflammationinflammation60.1%
Sinus perforation20%
Abscessa collection of pus10%
Anemialow red blood cells10%

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

In context

MeasureDymicProduct code DZEAll MAUDE reports
Reports6,1893,924,24126,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports009
Classified as injury100%99.2%36.2%
Classified as malfunction0%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 Dymic reports

How many FDA reports name Dymic?

6,189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 660 in the latest 12 months.

What kinds of events are reported?

injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to osseointegrate (92.9%), loss of osseointegration (6.8%), failure to disconnect (0.1%), fracture (0.1%) and failure to align (0%). 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 Dymic 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.