Device manufacturer, as written on reports

The Anspach Effort: medical device reports filed with FDA

4,372 reports name it as the manufacturer of the device involved, 1998–2026.

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.

4,372
reports naming it as manufacturer: 0% of all MAUDE reports; 17
reports, 12 months to August 2026: 10 in the 12 months before; 98.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

4,372 medical device reports received by FDA give The Anspach Effort as the manufacturer of the device involved, 0% of the MAUDE database, from April 1998 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

17 reports arrived in the 12 months to August 2026, up 70% from 10 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 (98.7%), other (0.6%) and injury (0.5%). 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
Emax 2 Plus Motor	Motor, drill, electric	409	62	0%
Blackmax System Motor	Motor, drill, pneumatic	358	0	0%
Xmax Motor	Drill, surgical, ent (electric or pneumatic) including handpiece	271	0	0%
Angled Micronose Attachment	Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment	246	0	0%
Micromax System Motor	Motor, drill, pneumatic	159	0	0%
Emax 2 Motor	Motor, drill, electric	121	0	0%
5 0 Cm Short Attachment	Motor, drill, electric	110	9	0%
Super Sucker Short Bx/20	Instrument, surgical, disposable	100	0	0%
11 0 Cm Long Attachment	Motor, drill, electric	73	0	0%
5 0cm Short Attachment	Motor, drill, electric	61	0	0%
Blackmax-Neuro	Motor, drill, pneumatic	55	0	0%
Super Sucker Short Curved Bx/20	Instrument, surgical, disposable	45	0	0%
11cm Angle Attachment	Motor, drill, electric	35	3	0%
1 85mm X 16mm Fluted Router	Motor, drill, electric	31	0	0%
System Console	Motor, drill, electric	23	0	0%
6 5cm Adult Crani Attachmt	Motor, drill, electric	19	41	0%
Minimal Access Attachment	Drills, burrs, trephines & accessories (simple, powered)	19	1	0%
2 15mm X 22mm Spiral Router	Motor, drill, electric	18	0	0%
8 0 Cm Medium Attachment	Motor, drill, electric	16	0	0%
6 5cm Adult Crani Attachment	Motor, drill, electric	15	0	0%
Perforator Driver W/Hudson End	Drills, burrs, trephines & accessories (simple, powered)	14	0	0%
1 55mm X 10mm Fluted Twist Drl	Motor, drill, electric	13	0	0%
12 4cm Heavy Duty Long Attch	Motor, drill, electric	12	0	0%
High Speed Elec G1 Handpiece Air Cooled	Motor, drill, electric	11	25	0.1%
8cm Angle Attachment	Motor, drill, electric	8	6	0%
Kincise Automated Surgical Impactor	Motor, surgical instrument, ac-powered	6	11	0%
Motor Assembly Xmax	Drill, surgical, ent (electric or pneumatic) including handpiece	6	14	0%
7 5cm Large Craniotome Attch	Motor, drill, electric	3	5	0%
8 Cm Short Qd Angle Attachment	Motor, drill, electric	3	1	0%
Adult Craniotome	Motor, drill, electric	3	9	0.2%

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
HBB	Motor, drill, pneumatic	1,241	28.4%
HBC	Motor, drill, electric	1,239	28.3%
ERL	Drill, surgical, ent (electric or pneumatic) including handpiece	840	19.2%
HSZ	Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment	328	7.5%
HBE	Drills, burrs, trephines & accessories (simple, powered)	290	6.6%
KDC	Instrument, surgical, disposable	170	3.9%
HBF	Drills, burrs, trephines & accessories (compound, powered)	72	1.6%
GEY	Motor, surgical instrument, ac-powered	65	1.5%
GFF	Bur, surgical, general & plastic surgery	57	1.3%
LRP	Tray, surgical	43	1%

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%1

Injury0.5%23

Malfunction98.7%4,314

Other0.6%27

Not given0.2%7

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

Questions about The Anspach Effort reports

How many FDA device reports name The Anspach Effort as manufacturer?

4,372 reports through August 2026, 17 of them in the latest 12 months.

Which of its brands appear most often?

Emax 2 Plus Motor (409), Blackmax System Motor (358), Xmax Motor (271), Angled Micronose Attachment (246) and Micromax System Motor (159).

Which device types does it report on?

motor, drill, pneumatic (28.4%), motor, drill, electric (28.3%), drill, surgical, ent (electric or pneumatic) including handpiece (19.2%) and instrument, surgical, orthopedic, pneumatic powered & accessory/attachment (7.5%).

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.