Device brand name · Cement dental
Maxcem Elite: medical device reports filed with FDA
516 reports name it, 2008–2014. Manufacturer given most often on reports: Kerr. Product code EMA.
- 516
- device reports naming the brand
- 0% of all MAUDE reports · about 29 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4.1%
- classified as malfunction
- 8.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
516 medical device reports received by FDA name the brand "Maxcem Elite" (cement dental); the manufacturer given most often on reports is Kerr; received from November 2008 to December 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (95.9%) and malfunction (4.1%); across all cement, dental reports (product code EMA) death is recorded in 0% and malfunction in 8.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are loss of or failure to bond (62.8%), nonstandard device (11%) and device operates differently than expected (10.7%). The patient problems coded most often are tooth fracture, injury and failure of implant. 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 Maxcem Elite was received in the five years to August 2026; the latest was received in December 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,630 reports carrying product code EMA. 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 |
|---|---|---|---|
| Loss of or failure to bond | 324 | 62.8% | 34.5% |
| Nonstandard device | 57 | 11% | 7.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 55 | 10.7% | 8% |
| Detachment of device component | 48 | 9.3% | 5.5% |
| Component falling | 31 | 6% | 4% |
| Failure to adhere or bond | 31 | 6% | 5.5% |
| Insufficient device problem information | 23 | 4.5% | 11.1% |
| Component missing | 15 | 2.9% | 1% |
| Material discolored | 14 | 2.7% | 5.6% |
| Delamination | 5 | 1% | 0.6% |
| Malposition of device | 4 | 0.8% | 0.3% |
| Material integrity problema problem with the device material | 3 | 0.6% | 1.2% |
| Device dislodged or dislocated | 2 | 0.4% | 0.3% |
| Leak/splashthe device leaked | 2 | 0.4% | 0.4% |
| Breakthe device broke | 1 | 0.2% | 0.4% |
| Device or device fragments location unknown | 1 | 0.2% | 0.2% |
| Difficult to removethe device was hard to remove | 1 | 0.2% | 1.2% |
| Other (for use when an appropriate device code cannot be identified) | 1 | 0.2% | 0.9% |
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 |
|---|---|---|
| Tooth fracture | 33 | 6.4% |
| Injurya physical injury | 32 | 6.2% |
| Failure of implant | 5 | 1% |
| Device embedded in tissue or plaque | 2 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.4% |
| Increased sensitivity | 2 | 0.4% |
| Swellingswelling | 2 | 0.4% |
| Adhesion(s) | 1 | 0.2% |
| Complaint, ill-defined | 1 | 0.2% |
| Erythemaskin redness | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Irritationirritation | 1 | 0.2% |
| Rashskin rash | 1 | 0.2% |
| Sensitivity of teeth | 1 | 0.2% |
| Surgical procedure | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Maxcem Elite | Product code EMA | All MAUDE reports |
|---|---|---|---|
| Reports | 516 | 1,630 | 26,136,888 |
| Share of that pool | — | 31.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 95.9% | 88.3% | 36.2% |
| Classified as malfunction | 4.1% | 8.6% | 62.3% |
| Filed by the manufacturer | 100% | 97.7% | 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 EMA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Nx3 | 154 | 0 | 0% |
| AdvanCE | 220 | 8 | 2.7% |
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 Maxcem Elite reports
How many FDA reports name Maxcem Elite?
516 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 (95.9%) and malfunction (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
loss of or failure to bond (62.8%), nonstandard device (11%), device operates differently than expected (10.7%), detachment of device component (9.3%) and component falling (6%). 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 Maxcem Elite 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.