Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Camlog guide system screw line implant promote plus

Camlog Guide System Screw Line Implant Promote Plus: medical device reports filed with FDA

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

163
device reports naming the brand
0% of all MAUDE reports · about 31 a year
10
reports, 12 months to August 2026
16 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 163 reports that name the brand "Camlog Guide System Screw Line Implant Promote Plus" (camlog guide system screw line implant promote plus), received between April 2021 and July 2026; the manufacturer given most often on reports is Altatec. Spellings of one product vary from report to report.

10 reports arrived in the 12 months to August 2026, down 37% from 16 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.

Reports by month, five years

03773Sep 2021: 4Oct 2021: 22Nov 2021: 73Dec 2021: 02022Jan 2022: 4Feb 2022: 1Mar 2022: 1Apr 2022: 1May 2022: 1Jun 2022: 0Jul 2022: 1Aug 2022: 0Sep 2022: 0Oct 2022: 1Nov 2022: 1Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 2Jul 2023: 0Aug 2023: 1Sep 2023: 2Oct 2023: 0Nov 2023: 0Dec 2023: 12024Jan 2024: 1Feb 2024: 2Mar 2024: 0Apr 2024: 1May 2024: 0Jun 2024: 4Jul 2024: 1Aug 2024: 1Sep 2024: 1Oct 2024: 1Nov 2024: 4Dec 2024: 42025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 3May 2025: 1Jun 2025: 0Jul 2025: 1Aug 2025: 1Sep 2025: 2Oct 2025: 0Nov 2025: 3Dec 2025: 02026Jan 2026: 1Feb 2026: 3Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 1Aug 2026: 0

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

0551102021: 11020212022: 1120222023: 620232024: 2020242025: 1120252026: 52026

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%163
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%163
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 osseointegration9055.2%22.4%
Failure to osseointegrate3722.7%62.8%

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.

In context

MeasureCamlog Guide System Screw Line Implant Promote PlusProduct code DZEAll MAUDE reports
Reports1633,924,24126,136,888
Share of that pool—0%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 Camlog Guide System Screw Line Implant Promote Plus reports

How many FDA reports name Camlog Guide System Screw Line Implant Promote Plus?

163 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 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 (55.2%) and failure to osseointegrate (22.7%). 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 Camlog Guide System 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.