Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Camlog screw-line implant promote plus

Camlog Screw-Line Implant Promote plus: medical device reports filed with FDA

23,027 reports name it, 2021–2026. Manufacturer given most often on reports: Altatec. Product code DZE.

23,027
device reports naming the brand
0.1% of all MAUDE reports · about 4,320 a year
1,733
reports, 12 months to August 2026
3,977 in the 12 months before
0%
classified as malfunction
0.8% across the product code
0%
classified as death, as reported
2 reports · not verified by FDA

23,027 medical device reports received by FDA name the brand "Camlog Screw-Line Implant Promote plus" (camlog 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.

1,733 reports arrived in the 12 months to August 2026, down 56% from 3,977 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 (63.4%), failure to osseointegrate (32.2%) and fracture (2.1%). The patient problems coded most often are intraoperative cardiac valve injury, appropriate clinical signs, symptoms and conditions term/code not available and bone cement implantation syndrome. 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

08671,734Sep 2021: 584Oct 2021: 1,734Nov 2021: 1,406Dec 2021: 1712022Jan 2022: 309Feb 2022: 111Mar 2022: 248Apr 2022: 347May 2022: 167Jun 2022: 232Jul 2022: 340Aug 2022: 537Sep 2022: 171Oct 2022: 105Nov 2022: 292Dec 2022: 1942023Jan 2023: 445Feb 2023: 306Mar 2023: 595Apr 2023: 436May 2023: 249Jun 2023: 433Jul 2023: 312Aug 2023: 337Sep 2023: 358Oct 2023: 211Nov 2023: 249Dec 2023: 2432024Jan 2024: 461Feb 2024: 688Mar 2024: 326Apr 2024: 420May 2024: 348Jun 2024: 277Jul 2024: 456Aug 2024: 348Sep 2024: 431Oct 2024: 213Nov 2024: 398Dec 2024: 2592025Jan 2025: 348Feb 2025: 77Mar 2025: 405Apr 2025: 293May 2025: 161Jun 2025: 332Jul 2025: 506Aug 2025: 554Sep 2025: 241Oct 2025: 213Nov 2025: 222Dec 2025: 2222026Jan 2026: 165Feb 2026: 223Mar 2026: 185Apr 2026: 225May 2026: 0Jun 2026: 0Jul 2026: 23Aug 2026: 14

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

03,3836,7662021: 6,76620212022: 3,05320222023: 4,17420232024: 4,62520242025: 3,57420252026: 8352026

Event type and report source

Event type, as classified on the report

Death0%2
Injury100%23,023
Malfunction0%2
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%23,027
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 osseointegration14,59863.4%22.4%
Failure to osseointegrate7,40532.2%62.8%
Fracturea broken bone4952.1%1.6%
Device-device incompatibility100%0%
Failure to zero30%0%
Material frayed10%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 injury50%
Appropriate clinical signs, symptoms and conditions term/code not available20%
Bone cement implantation syndrome20%
Failure of implant20%
Cramp(s) /muscle spasm(s)10%
Facial paralysis10%
Joint contracture10%

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

In context

MeasureCamlog Screw-Line Implant Promote plusProduct code DZEAll MAUDE reports
Reports23,0273,924,24126,136,888
Share of that pool—0.6%0.1%
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 Screw-Line Implant Promote plus reports

How many FDA reports name Camlog Screw-Line Implant Promote plus?

23,027 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,733 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 (63.4%), failure to osseointegrate (32.2%), fracture (2.1%), device-device incompatibility (0%) and failure to zero (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 Camlog 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.