Reported Reactions

Devices › Drill, surgical, ent (electric or pneumatic) including handpiece

Device brand name · Unit operative dental

Micro Drill Medium Straight Attachment: medical device reports filed with FDA

312 reports name it, 2008–2016. Manufacturer given most often on reports: Stryker Instruments Kalamazoo. Product code ERL.

312
device reports naming the brand
0% of all MAUDE reports · about 17 a year
0
reports, 12 months to August 2026
0 in the 12 months before
89.4%
classified as malfunction
98.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

312 medical device reports received by FDA name the brand "Micro Drill Medium Straight Attachment" (unit operative dental); the manufacturer given most often on reports is Stryker Instruments Kalamazoo; received from February 2008 to July 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 malfunction (89.4%) and injury (10.3%); across all drill, surgical, ent (electric or pneumatic) including handpiece reports (product code ERL) death is recorded in 0% and malfunction in 98.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are overheating of device (63.1%), temperature problem (9.3%) and insufficient device problem information (4.2%). The patient problems coded most often are no patient involvement, burn(s) and burn, thermal. 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

No report naming Micro Drill Medium Straight Attachment was received in the five years to August 2026; the latest was received in July 2016.

By year received

043852008: 420082009: 1920092010: 3220102011: 6320112012: 6520122013: 1620132014: 8520142015: 1620152016: 122016

Event type and report source

Event type, as classified on the report

Death0%0
Injury10.3%32
Malfunction89.4%279
Other0%0
Not given0.3%1

Who filed the report

Manufacturer report100%312
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 29,931 reports carrying product code ERL. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Overheating of device19763.1%43.4%
Temperature problem299.3%2.5%
Insufficient device problem information134.2%0.1%
Disassembly103.2%0.6%
Leak/splashthe device leaked103.2%2%
Breakthe device broke72.2%5.2%
Fluid/blood leak72.2%3%
Mechanical problema mechanical problem51.6%0.6%
Sticking41.3%0.4%
Unintended movement41.3%0.6%
Unstable41.3%0.1%
Component falling31%0.1%
Device operates differently than expectedthe device behaved unexpectedly31%3%
Detachment of device component20.6%0.5%
Device inoperablethe device could not be used20.6%1.5%
Loss of powerthe device lost power20.6%0.3%
Metal shedding debris20.6%0.2%
Smoking20.6%0.6%
Compatibility problem10.3%0%
Device contamination with chemical or other material10.3%0.2%

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)ReportsShare
No patient involvement11536.9%
Burn(s)a burn206.4%
Burn, thermal175.4%
Partial thickness (second degree) burn51.6%
Superficial (first degree) burn41.3%
Skin discoloration20.6%
Swellingswelling20.6%
Chemical exposure10.3%
Erythemaskin redness10.3%
Exposure to body fluids10.3%
Full thickness (third degree) burn10.3%
Therapeutic effects, unexpected10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMicro Drill Medium Straight AttachmentProduct code ERLAll MAUDE reports
Reports31229,93126,136,888
Share of that pool—1%0%
Classified as death, per 1,000 reports009
Classified as injury10.3%0.9%36.2%
Classified as malfunction89.4%98.9%62.3%
Filed by the manufacturer100%99.5%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 ERL

BrandReportsLatest 12 monthsClassified as death
Xmax Motor4,44700%
Remb Electric Sagittal Saw1,69340%
Core Impaction Drill3,91300%
S2 Drill844790%
Motor Assembly Xmax893140%
Ipc Handpiece - Xps Straightshot M57111240%
Remb Electric Micro Drill66090%
Xps Handpiece - Visao649120%
Ipc Handpiece - Xps Straightshot M4607450%
Pi Drive Plus Motor56400%
Micro Sagittal Saw1,39500%
Core Universal Driver67900%
ENT Mr86225380%
Pi Drive Motor47700%
Core Sumex Drill52200%

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 Micro Drill Medium Straight Attachment reports

How many FDA reports name Micro Drill Medium Straight Attachment?

312 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?

malfunction (89.4%) and injury (10.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

overheating of device (63.1%), temperature problem (9.3%), insufficient device problem information (4.2%), disassembly (3.2%) and leak/splash (3.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Micro Drill Medium Straight Attachment 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.