Accessories, implant, dental, endosseous: medical device reports filed with FDA

5,022 reports carry this product code, 2007–2026; 24 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,022
reports with this product code: 0% of all MAUDE reports; 2,779
reports, 12 months to August 2026: 217 in the 12 months before; 81.1%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code NDP is FDA's classification for "Accessories, implant, dental, endosseous" (dental panel), a class 1 device. 5,022 medical device reports carry this product code, 0% of the MAUDE database, from April 2007 to August 2026.

2,779 reports arrived in the 12 months to August 2026, up 1181% from 217 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 malfunction (81.1%) and injury (18.9%). 24 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Implant Driver EV (S) long	406	411	0%	97.8%
Implant Driver EV (M) long	319	324	0%	99.1%
Implant Driver EV (L) long	284	291	0%	98.3%
Implant Driver EV (XS) long	265	270	0%	100%
Anatomage Guide	242	0	0%	4.5%
Implant Driver EV (S) short	176	186	0%	97.8%
Implant Driver EV (L) short	154	155	0%	98.7%
Unk Mis	11	800	0%	1.3%
Dental Implant	4	29	0%	8.3%
OsseoSpeed TX 3.5S - 11 mm	4	769	0%	0%
Torque wrench	4	13	0%	95%
Unknown Ankylos CX abutment	4	139	0%	11.4%
OmniTaper EV 3.4 x 9.5mm OsseoSpeed	3	104	0%	0%
Unknown ATIS abutment	3	142	0%	4.6%
BioHorizons Inc.	2	25,536	0%	0%
ANK C/X Impl C8/D5.5/L8	1	55	0%	0%
AstraTech Impl EV 4.2PS 9mm OS	1	56	0%	0.5%
C1 XD coni. con. implant D5 L8mm , WP	1	98	0%	0%
Certain Titanium Hexed Screw	1	21	0%	87.2%
Driver	1	27	0%	98.6%
Osseospeed Ev 4 8 C - 13 Mm	1	37	0%	0%
OsseoSpeed TX 4.0S - 11 mm	1	763	0%	0%
OsseoSpeed TX 4.0S - 9 mm	1	877	0%	0%
PrimeTaper EV 3.6 x 11mm OS	1	458	0%	0.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Dentsply Implants A Division Of Dentsply Ih	2,006	39.9%
Biomet 3i	875	17.4%
Dentsply Implants Manufacturing	542	10.8%
Zimmer Dental	386	7.7%
Implant Direct Sybron Manufacturing	206	4.1%
Zimvie US	127	2.5%
Mis Implants Technologies	102	2%
Prismatik Dentalcraft	84	1.7%
Keystone Dental	42	0.8%
Biohorizons	29	0.6%
Becton Dickinson Medical Singapore	26	0.5%
Biohorizons Implant Systems	25	0.5%
Institut Straumann	6	0.1%
Adin Dental Implant Systems	5	0.1%
Nobel Biocare USA	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%0

Injury18.9%948

Malfunction81.1%4,072

Other0%2

Not given0%0

Who filed

Manufacturer report99.6%5,004

Voluntary report0.3%13

User facility report0%0

Distributor report0.1%3

Not given0%2

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Fracturea broken bone	2,735	54.5%
Mechanical problema mechanical problem	601	12%
Separation failure	440	8.8%
Detachment of device or device componentpart of the device came off	296	5.9%
Breakthe device broke	76	1.5%
Material deformation	54	1.1%
Positioning failure	47	0.9%
Malposition of device	40	0.8%
Mechanical jam	40	0.8%
Device damaged by another device	35	0.7%
Insufficient device problem information	34	0.7%
Loose or intermittent connection	21	0.4%
Sticking	19	0.4%
Failure to osseointegrate	18	0.4%
Defective devicethe device was defective	14	0.3%
Device operates differently than expectedthe device behaved unexpectedly	14	0.3%
Difficult to removethe device was hard to remove	14	0.3%
Manufacturing, packaging or shipping problem	14	0.3%
Osseointegration problem	14	0.3%
Positioning problem	13	0.3%

Questions about accessories, implant, dental, endosseous reports

What is product code NDP?

FDA's classification code for "Accessories, implant, dental, endosseous", class 1, reviewed by the dental panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,022 reports through August 2026, 2,779 of them in the latest 12 months.

Which brands appear most often?

Implant Driver EV (S) long (406), Implant Driver EV (M) long (319), Implant Driver EV (L) long (284), Implant Driver EV (XS) long (265) and Anatomage Guide (242). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.