Devices › Accessories, implant, dental, endosseous
Device brand name · Surgical guide
Anatomage Guide: medical device reports filed with FDA
243 reports name it, 2014–2022. Manufacturer given most often on reports: Anatomage. Product code NDP.
- 243
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4.5%
- classified as malfunction
- 81.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 243 reports that name the brand "Anatomage Guide" (surgical guide), received between July 2014 and February 2022; the manufacturer given most often on reports is Anatomage. Spellings of one product vary from report to report.
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 (95.5%) and malfunction (4.5%); across all accessories, implant, dental, endosseous reports (product code NDP) death is recorded in 0% and malfunction in 81.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are manufacturing, packaging or shipping problem (5.3%), product quality problem (2.5%) and fracture (1.6%). The patient problems coded most often are perforation, 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,022 reports carrying product code NDP. 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 |
|---|---|---|---|
| Manufacturing, packaging or shipping problem | 13 | 5.3% | 0.3% |
| Product quality problem | 6 | 2.5% | 0.2% |
| Fracturea broken bone | 4 | 1.6% | 54.5% |
| Breakthe device broke | 3 | 1.2% | 1.5% |
| Material fragmentation | 3 | 1.2% | 0.1% |
| Material integrity problema problem with the device material | 3 | 1.2% | 0.1% |
| Positioning problem | 3 | 1.2% | 0.3% |
| Compatibility problem | 2 | 0.8% | 0% |
| Device dislodged or dislocated | 2 | 0.8% | 0% |
| Device-device incompatibility | 2 | 0.8% | 0.2% |
| Difficult to position | 2 | 0.8% | 0.1% |
| Insufficient device problem information | 2 | 0.8% | 0.7% |
| Defective devicethe device was defective | 1 | 0.4% | 0.3% |
| Detachment of device component | 1 | 0.4% | 0.2% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.4% | 0.1% |
| Fitting problem | 1 | 0.4% | 0% |
| Improper or incorrect procedure or method | 1 | 0.4% | 0.2% |
| Malposition of device | 1 | 0.4% | 0.8% |
| Material perforation | 1 | 0.4% | 0% |
| Material torqued | 1 | 0.4% | 0.1% |
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 |
|---|---|---|
| Perforation | 39 | 16% |
| Injurya physical injury | 27 | 11.1% |
| Failure of implant | 10 | 4.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 6 | 2.5% |
| Sinus perforation | 5 | 2.1% |
| Numbnessnumbness | 4 | 1.6% |
| Nerve damage | 2 | 0.8% |
| Tissue damage | 2 | 0.8% |
| Bone fracture(s) | 1 | 0.4% |
| Inadequate osseointegration | 1 | 0.4% |
| Infiltration into tissue | 1 | 0.4% |
| Nerve proximity NOS (not otherwise specified) | 1 | 0.4% |
| Organ dehiscence | 1 | 0.4% |
| Sensitivity of teeth | 1 | 0.4% |
| Tissue breakdown | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Anatomage Guide | Product code NDP | All MAUDE reports |
|---|---|---|---|
| Reports | 243 | 5,022 | 26,136,888 |
| Share of that pool | — | 4.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 95.5% | 18.9% | 36.2% |
| Classified as malfunction | 4.5% | 81.1% | 62.3% |
| Filed by the manufacturer | 99.2% | 99.6% | 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 NDP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Implant Driver EV (S) long | 411 | 411 | 0% |
| Implant Driver EV (M) long | 324 | 324 | 0% |
| Implant Driver EV (L) long | 291 | 291 | 0% |
| Implant Driver EV (XS) long | 270 | 270 | 0% |
| Implant Driver EV (S) short | 186 | 186 | 0% |
| Implant Driver EV (L) short | 156 | 155 | 0% |
| Unk Mis | 1,554 | 800 | 0% |
| Dental Implant | 399 | 29 | 0% |
| OsseoSpeed TX 3.5S - 11 mm | 6,287 | 769 | 0% |
| Torque wrench | 180 | 13 | 0% |
| Unknown Ankylos CX abutment | 272 | 139 | 0% |
| OmniTaper EV 3.4 x 9.5mm OsseoSpeed | 189 | 104 | 0% |
| Unknown ATIS abutment | 388 | 142 | 0% |
| BioHorizons Inc. | 57,020 | 25,536 | 0% |
| ANK C/X Impl C8/D5.5/L8 | 373 | 55 | 0% |
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 Anatomage Guide reports
How many FDA reports name Anatomage Guide?
243 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 (95.5%) and malfunction (4.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
manufacturing, packaging or shipping problem (5.3%), product quality problem (2.5%), fracture (1.6%), break (1.2%) and material fragmentation (1.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Anatomage Guide 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.