Device manufacturer, as written on reports

Zimmer Dental: medical device reports filed with FDA

22,716 reports name it as the manufacturer of the device involved, 2009–2025.

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.

22,716
reports naming it as manufacturer: 0.1% of all MAUDE reports; 487
reports, 12 months to August 2026: 3,718 in the 12 months before; 16.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

22,716 medical device reports received by FDA give Zimmer Dental as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2009 to October 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

487 reports arrived in the 12 months to August 2026, down 87% from 3,718 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 (83.5%) and malfunction (16.5%). 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
Impl Tapered Scr-V Sbm 3 7mm 3 5mm 10mm	Implant, endosseous, root-form	1,179	191	0%
Impl Tapered Scr-V Sbm 4 7mm 4 5mm 10mm	Implant, endosseous, root-form	1,097	187	0%
Impl Tapered Scr-V Mtx 3 7mm 3 5mm 11 5mm	Implant, endosseous, root-form	902	136	0%
Imp Tsv 4 7 10 Mtx Mg	Implant, endosseous, root-form	753	113	0%
Imp Tsv 4 1mm Sbm 10	Implant, endosseous, root-form	719	111	0%
Impl Tapered Scr-V Sbm 3 7mm 3 5mm 13mm	Implant, endosseous, root-form	624	103	0%
Imp Tsv 3 7 10 Mtx Mg	Implant, endosseous, root-form	597	129	0%
Impl Tapered Scr-V Sbm 4 7mm 4 5mm 11 5mm	Implant, endosseous, root-form	538	91	0%
Imp Tsv 4 1mm Sbm 11 5	Implant, endosseous, root-form	527	66	0%
Imp Tsv 3 7 11 5 Mtx Mg	Implant, endosseous, root-form	513	84	0%
Impl Tapered Scr-V Sbm 4 7mm 4 5mm 8mm	Implant, endosseous, root-form	511	96	0%
Imp Tsv 4 7 11 5 Mtx Mg	Implant, endosseous, root-form	432	65	0%
Impl Tapered Scr-V Sbm 3 7mm 3 5mm 8mm	Implant, endosseous, root-form	395	99	0%
Imp Tsv 4 1 10 Mtx Mg	Implant, endosseous, root-form	392	63	0%
Imp Tsv 3 7 13 Mtx Mg	Implant, endosseous, root-form	327	45	0%
Imp Tsv 4 1 11 5 Mtx Mg	Implant, endosseous, root-form	313	34	0%
Impl Tapered Scr-V Sbm 4 7mm 4 5mm 13mm	Implant, endosseous, root-form	307	43	0%
Imp Tsv 4 1mm Sbm 8	Implant, endosseous, root-form	301	49	0%
Imp Tsv 4 1mm Dual Sel Ha	Implant, endosseous, root-form	288	49	0%
Impl Tapered Scr-V Ha 4 7 Mm 4 5mm 10mm	Implant, endosseous, root-form	263	39	0%
Imp Tsv 4 7 8 Mtx Mg	Implant, endosseous, root-form	260	38	0%
Impl Tapered Scr-V Ha 3 7 Mm 3 5mm 10mm	Implant, endosseous, root-form	253	46	0%
Imp Tsv Mcol Mg 3 7mm 10m	Implant, endosseous, root-form	242	65	0%
Imp Tsv 6 0 10 Mtx Mg	Implant, endosseous, root-form	239	34	0%
Impl Tapered Scr-V Sbm 6m M 5 7mm 10mm	Implant, endosseous, root-form	219	45	0%
Impl Tapered Scr-V Ha 3 7 Mm 3 5mm 13mm	Implant, endosseous, root-form	214	16	0%
Imp Tsv Mcol Mg 4 7mm 10m	Implant, endosseous, root-form	213	53	0%
Imp Tsv 4 1mm Sbm 13	Implant, endosseous, root-form	209	57	0%
Scr Replace Friction-Fit Gold & Ti Abut Int Hex	Implant, endosseous, root-form	207	138	0%
Imp Tsv 4 7 13 Mtx Mg	Implant, endosseous, root-form	127	25	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	21,562	94.9%
NHA	Abutment, implant, dental, endosseous	764	3.4%
NDP	Accessories, implant, dental, endosseous	386	1.7%
HWC	Screw, fixation, bone	30	0.1%
DZA	Drill, dental, intraoral	6	0%
DZL	Screw, fixation, intraosseous	4	0%
FZX	Guide, surgical, instrument	2	0%
LYC	Bone grafting material, synthetic	2	0%
HTW	Bit, drill	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

Death0%0

Injury83.5%18,959

Malfunction16.5%3,757

Other0%0

Not given0%0

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

Questions about Zimmer Dental reports

How many FDA device reports name Zimmer Dental as manufacturer?

22,716 reports through August 2026, 487 of them in the latest 12 months.

Which of its brands appear most often?

Impl Tapered Scr-V Sbm 3 7mm 3 5mm 10mm (1,179), Impl Tapered Scr-V Sbm 4 7mm 4 5mm 10mm (1,097), Impl Tapered Scr-V Mtx 3 7mm 3 5mm 11 5mm (902), Imp Tsv 4 7 10 Mtx Mg (753) and Imp Tsv 4 1mm Sbm 10 (719).

Which device types does it report on?

implant, endosseous, root-form (94.9%), abutment, implant, dental, endosseous (3.4%), accessories, implant, dental, endosseous (1.7%) and screw, fixation, bone (0.1%).

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.