Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Stryker Instruments: medical device reports filed with FDA

1,463 reports name it as the manufacturer of the device involved, 1992–2026.

1,463
reports naming it as manufacturer
0% of all MAUDE reports
78
reports, 12 months to August 2026
84 in the 12 months before
64.5%
classified as malfunction
62.3% across all reports
0.5%
classified as death, as reported
0.9% across all reports

1,463 medical device reports received by FDA give Stryker Instruments as the manufacturer of the device involved, 0% of the MAUDE database, from July 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

78 reports arrived in the 12 months to August 2026, close to the 84 of 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 (64.5%), injury (30.6%) and other (2.1%). 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

BrandDevice typeReportsLatest 12 monthsClassified as death
StrykerPump, infusion, elastomeric4051.3%
Core Impaction DrillDriver, wire, and bone drill, manual2700%
Core Micro DrillDrill, surgical, ent (electric or pneumatic) including handpiece900%
Tps Micro DriverDrill, surgical, ent (electric or pneumatic) including handpiece800%
Sagittal BladeBlade, saw, general & plastic surgery, surgical600%
Universal High Torque DrillDrill, surgical, ent (electric or pneumatic) including handpiece600%
Core Sumex DrillDrill, surgical, ent (electric or pneumatic) including handpiece500%
Micro Drill Medium Straight AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece500%
Micro Sagittal SawDrills, burrs, trephines & accessories (simple, powered)500%
Tps Universal DriverDrill, surgical, ent (electric or pneumatic) including handpiece500%
Angled Long Saber AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece400.5%
Core Universal DriverDrill, surgical, ent (electric or pneumatic) including handpiece400%
Pin ColletInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment400%
Drill BitBit, drill3250%
Micro DrillDrill, surgical, ent (electric or pneumatic) including handpiece300%
Micro Reciprocating SawDrill, surgical, ent (electric or pneumatic) including handpiece300%
2.3mm Tapered RouterDrills, burrs, trephines & accessories (simple, powered)2100%
Pi Drive Plus MotorDrill, surgical, ent (electric or pneumatic) including handpiece200%
Serfas Energy Super 90-SElectrosurgical, cutting & coagulation & accessories200%
System 5 Sagittal SawInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment200%
System 6 Aseptic Housing AssyInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment200%
Cast CutterSaw, powered, and accessories100%
Cordless Driver 2 HandpieceArthroscope100%
Dual Trigger RotaryInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment100%
Essx HandpieceDrill, surgical, ent (electric or pneumatic) including handpiece180%
Impaction Bur GuardInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment100%
LigaSureElectrosurgical, cutting & coagulation & accessories18790.2%
LigaSure ImpactElectrosurgical, cutting & coagulation & accessories1720.3%
Maestro DrillMotor, drill, pneumatic100%
Maestro Medium Fixed DuraguardMotor, drill, pneumatic100%

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 codeDevice typeReportsShare
MEBPump, infusion, elastomeric1258.5%
EJLBur, dental1077.3%
ERLDrill, surgical, ent (electric or pneumatic) including handpiece956.5%
GFABlade, saw, general & plastic surgery, surgical896.1%
HWEInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment674.6%
HBEDrills, burrs, trephines & accessories (simple, powered)614.2%
GEIElectrosurgical, cutting & coagulation & accessories594%
DZIDrill, bone, powered573.9%
HTWBit, drill483.3%
FQHLavage, jet422.9%

Reports by month, five years

0917Sep 2021: 1Oct 2021: 1Nov 2021: 1Dec 2021: 22022Jan 2022: 1Feb 2022: 2Mar 2022: 0Apr 2022: 2May 2022: 2Jun 2022: 0Jul 2022: 5Aug 2022: 4Sep 2022: 1Oct 2022: 1Nov 2022: 5Dec 2022: 22023Jan 2023: 2Feb 2023: 1Mar 2023: 17Apr 2023: 5May 2023: 4Jun 2023: 5Jul 2023: 7Aug 2023: 6Sep 2023: 10Oct 2023: 7Nov 2023: 10Dec 2023: 42024Jan 2024: 7Feb 2024: 10Mar 2024: 5Apr 2024: 4May 2024: 1Jun 2024: 8Jul 2024: 4Aug 2024: 1Sep 2024: 6Oct 2024: 7Nov 2024: 11Dec 2024: 112025Jan 2025: 5Feb 2025: 3Mar 2025: 8Apr 2025: 4May 2025: 7Jun 2025: 12Jul 2025: 1Aug 2025: 9Sep 2025: 6Oct 2025: 2Nov 2025: 6Dec 2025: 52026Jan 2026: 11Feb 2026: 5Mar 2026: 9Apr 2026: 7May 2026: 3Jun 2026: 14Jul 2026: 2Aug 2026: 8

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

Event type

Death0.5%8
Injury30.6%448
Malfunction64.5%944
Other2.1%30
Not given2.3%33

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

Questions about Stryker Instruments reports

How many FDA device reports name Stryker Instruments as manufacturer?

1,463 reports through August 2026, 78 of them in the latest 12 months.

Which of its brands appear most often?

Stryker (40), Core Impaction Drill (27), Core Micro Drill (9), Tps Micro Driver (8) and Sagittal Blade (6).

Which device types does it report on?

pump, infusion, elastomeric (8.5%), bur, dental (7.3%), drill, surgical, ent (electric or pneumatic) including handpiece (6.5%) and blade, saw, general & plastic surgery, surgical (6.1%).

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.