Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Camlog screw-line implant promote

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

11,598 reports name it, 2021–2026. Manufacturer given most often on reports: Altatec. Product code DZE.

11,598
device reports naming the brand
0% of all MAUDE reports · about 2,176 a year
1,989
reports, 12 months to August 2026
1,833 in the 12 months before
0%
classified as malfunction
0.8% across the product code
0%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 11,598 reports that name the brand "Camlog Screw-Line Implant Promote" (camlog screw-line implant promote), received between March 2021 and August 2026; the manufacturer given most often on reports is Altatec. Spellings of one product vary from report to report.

1,989 reports arrived in the 12 months to August 2026, close to the 1,833 of 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 (65.1%), failure to osseointegrate (29.7%) and fracture (3.1%). The patient problems coded most often are intraoperative cardiac valve injury, facial paralysis and appropriate clinical signs, symptoms and conditions term/code not available. 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

0342683Sep 2021: 347Oct 2021: 683Nov 2021: 595Dec 2021: 962022Jan 2022: 125Feb 2022: 47Mar 2022: 96Apr 2022: 170May 2022: 59Jun 2022: 95Jul 2022: 109Aug 2022: 251Sep 2022: 98Oct 2022: 72Nov 2022: 130Dec 2022: 1382023Jan 2023: 187Feb 2023: 157Mar 2023: 247Apr 2023: 201May 2023: 89Jun 2023: 196Jul 2023: 205Aug 2023: 140Sep 2023: 142Oct 2023: 123Nov 2023: 110Dec 2023: 1022024Jan 2024: 229Feb 2024: 349Mar 2024: 186Apr 2024: 151May 2024: 129Jun 2024: 151Jul 2024: 91Aug 2024: 143Sep 2024: 163Oct 2024: 79Nov 2024: 212Dec 2024: 1012025Jan 2025: 149Feb 2025: 30Mar 2025: 194Apr 2025: 154May 2025: 120Jun 2025: 192Jul 2025: 224Aug 2025: 215Sep 2025: 124Oct 2025: 89Nov 2025: 152Dec 2025: 1812026Jan 2026: 114Feb 2026: 172Mar 2026: 98Apr 2026: 195May 2026: 32Jun 2026: 57Jul 2026: 554Aug 2026: 221

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

01,5293,0582021: 3,05820212022: 1,39020222023: 1,89920232024: 1,98420242025: 1,82420252026: 1,4432026

Event type and report source

Event type, as classified on the report

Death0%1
Injury100%11,596
Malfunction0%1
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%11,598
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 osseointegration7,55165.1%22.4%
Failure to osseointegrate3,44129.7%62.8%
Fracturea broken bone3623.1%1.6%
Device-device incompatibility70.1%0%
Failure to zero30%0%
Dull, blunt10%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 injury70.1%
Facial paralysis20%
Appropriate clinical signs, symptoms and conditions term/code not available10%
Bone cement implantation syndrome10%
Easy bruising10%

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

In context

MeasureCamlog Screw-Line Implant PromoteProduct code DZEAll MAUDE reports
Reports11,5983,924,24126,136,888
Share of that pool—0.3%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 Screw-Line Implant Promote reports

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

11,598 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,989 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 (65.1%), failure to osseointegrate (29.7%), fracture (3.1%), device-device incompatibility (0.1%) 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 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.