Device manufacturer, as written on reports

Biomet 3i: medical device reports filed with FDA

18,767 reports name it as the manufacturer of the device involved, 2007–2025.

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.

18,767
reports naming it as manufacturer: 0.1% of all MAUDE reports; 384
reports, 12 months to August 2026: 3,069 in the 12 months before; 33.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

18,767 medical device reports received by FDA give Biomet 3i as the manufacturer of the device involved, 0.1% of the MAUDE database, from March 2007 to October 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

384 reports arrived in the 12 months to August 2026, down 87% from 3,069 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 (66.1%) and malfunction (33.9%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Certain Gold-Tite Hexed Screw	Abutment, implant, dental, endosseous	1,297	91	0%
Certain Titanium Hexed Screw	Abutment, implant, dental, endosseous	410	21	0%
Osseotite Tapered Certain Implant 4 X 10mm	Implant, endosseous, root-form	333	57	0%
Titanium Hexed Uniscrew	Abutment, implant, dental, endosseous	286	16	0%
3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm	Implant, endosseous, root-form	251	4	0%
Osseotite Tapered Certain Implant 4 X 11 5mm	Implant, endosseous, root-form	239	42	0%
Certain Titanium Large Hexed Screw	Implant, endosseous, root-form	231	17	0%
3i T3 Non-Platform Switched Tapered Implant 4 X 10mm	Implant, endosseous, root-form	224	14	0%
Bellatek Zirconia Abutment	Abutment, implant, dental, endosseous	222	0	0%
3i T3 Tapered Implant 5/4 X 10mm	Implant, endosseous, root-form	205	2	0%
Certain Gold-Tite Tm Hexed Screw	Abutment, implant, dental, endosseous	176	11	0%
3i T3 Non-Platform Switched Tapered Implant 3 25 X 11 5mm	Implant, endosseous, root-form	171	9	0%
3i T3 Non-Platform Switched Tapered Implant 4 X 13mm	Implant, endosseous, root-form	170	11	0%
Gold-Tite Square Uniscrew	Abutment, implant, dental, endosseous	157	7	0%
Osseotite Tapered Certain Implant 3 25 X 11 5mm	Implant, endosseous, root-form	152	30	0%
3i T3 Tapered Implant 4/3 X 10mm	Implant, endosseous, root-form	151	8	0%
3i T3 Tapered Implant 4/3 X 11 5mm	Implant, endosseous, root-form	150	6	0%
Osseotite Tapered Certain Implant 5 X 10mm	Implant, endosseous, root-form	134	28	0%
Osseotite Tapered Certain Prevail Implant 4/3 X 11 5mm	Implant, endosseous, root-form	127	17	0%
Tsx Implant 4 7mmd 10mml	Implant, endosseous, root-form	83	95	0%
Osseotite Tapered Certain Implant 3 25 X 10mm	Implant, endosseous, root-form	82	22	0%
Unknown Screw	Screw, fixation, bone	24	156	0%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
DZE	Implant, endosseous, root-form	13,143	70%
NHA	Abutment, implant, dental, endosseous	4,700	25%
NDP	Accessories, implant, dental, endosseous	875	4.7%
HWC	Screw, fixation, bone	77	0.4%
DZL	Screw, fixation, intraosseous	26	0.1%
HWR	Driver, prosthesis	7	0%
DZA	Drill, dental, intraoral	4	0%
EBW	Controller, foot, handpiece and cord	2	0%
GFF	Bur, surgical, general & plastic surgery	2	0%
LXH	Orthopedic manual surgical instrument	2	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

Death0%0

Injury66.1%12,398

Malfunction33.9%6,368

Other0%0

Not given0%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Biomet 3i reports

How many FDA device reports name Biomet 3i as manufacturer?

18,767 reports through August 2026, 384 of them in the latest 12 months.

Which of its brands appear most often?

Certain Gold-Tite Hexed Screw (1,297), Certain Titanium Hexed Screw (410), Osseotite Tapered Certain Implant 4 X 10mm (333), Titanium Hexed Uniscrew (286) and 3i T3 Non-Platform Switched Tapered Implant 4 X 11 5mm (251).

Which device types does it report on?

implant, endosseous, root-form (70%), abutment, implant, dental, endosseous (25%), accessories, implant, dental, endosseous (4.7%) and screw, fixation, bone (0.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.