Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Conelog screw-line implant promote plus

CONELOG SCREW-LINE Implant, Promote plus: medical device reports filed with FDA

6,479 reports name it, 2021–2026. Manufacturer given most often on reports: Altatec. Product code DZE.

6,479
device reports naming the brand
0% of all MAUDE reports · about 1,215 a year
1,191
reports, 12 months to August 2026
919 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

6,479 medical device reports received by FDA name the brand "CONELOG SCREW-LINE Implant, Promote plus" (conelog screw-line implant promote plus); the manufacturer given most often on reports is Altatec; received from March 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

1,191 reports arrived in the 12 months to August 2026, up 30% from 919 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 loss of osseointegration (57.2%), failure to osseointegrate (39.4%) and fracture (0.5%). The patient problems coded most often are intraoperative cardiac valve injury and menorrhagia. 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

0189378Sep 2021: 179Oct 2021: 378Nov 2021: 359Dec 2021: 372022Jan 2022: 85Feb 2022: 43Mar 2022: 59Apr 2022: 69May 2022: 54Jun 2022: 61Jul 2022: 89Aug 2022: 144Sep 2022: 61Oct 2022: 33Nov 2022: 90Dec 2022: 612023Jan 2023: 106Feb 2023: 77Mar 2023: 103Apr 2023: 99May 2023: 64Jun 2023: 110Jul 2023: 98Aug 2023: 91Sep 2023: 73Oct 2023: 49Nov 2023: 85Dec 2023: 302024Jan 2024: 124Feb 2024: 94Mar 2024: 88Apr 2024: 109May 2024: 70Jun 2024: 92Jul 2024: 154Aug 2024: 95Sep 2024: 93Oct 2024: 55Nov 2024: 82Dec 2024: 632025Jan 2025: 85Feb 2025: 17Mar 2025: 96Apr 2025: 78May 2025: 38Jun 2025: 83Jul 2025: 100Aug 2025: 129Sep 2025: 86Oct 2025: 56Nov 2025: 83Dec 2025: 1052026Jan 2026: 66Feb 2026: 99Mar 2026: 98Apr 2026: 125May 2026: 11Jun 2026: 34Jul 2026: 296Aug 2026: 132

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

08551,7092021: 1,70920212022: 84920222023: 98520232024: 1,11920242025: 95620252026: 8612026

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%6,479
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%6,479
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
Loss of osseointegration3,70457.2%22.4%
Failure to osseointegrate2,55239.4%62.8%
Fracturea broken bone330.5%1.6%
Device-device incompatibility40.1%0%
No fail-safe mechanism20%0%

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
Intraoperative cardiac valve injury20%
Menorrhagiaheavy periods10%

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

In context

MeasureCONELOG SCREW-LINE Implant, Promote plusProduct code DZEAll MAUDE reports
Reports6,4793,924,24126,136,888
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 CONELOG SCREW-LINE Implant, Promote plus reports

How many FDA reports name CONELOG SCREW-LINE Implant, Promote plus?

6,479 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,191 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?

loss of osseointegration (57.2%), failure to osseointegrate (39.4%), fracture (0.5%), device-device incompatibility (0.1%) and no fail-safe mechanism (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 CONELOG SCREW-LINE Implant, Promote plus 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.