Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Stryker Instruments Kalamazoo: medical device reports filed with FDA

12,286 reports name it as the manufacturer of the device involved, 2004–2013.

12,286
reports naming it as manufacturer
0.1% of all MAUDE reports
0
reports, 12 months to August 2026
0 in the 12 months before
94.9%
classified as malfunction
62.3% across all reports
0.1%
classified as death, as reported
0.9% across all reports

12,286 medical device reports received by FDA give Stryker Instruments Kalamazoo as the manufacturer of the device involved, 0.1% of the MAUDE database, from June 2004 to December 2013. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 (94.9%), injury (4.9%) and death (0.1%). 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
Core Impaction DrillDriver, wire, and bone drill, manual1,17800%
Micro Sagittal SawDrills, burrs, trephines & accessories (simple, powered)94600%
Core Micro DrillDrill, surgical, ent (electric or pneumatic) including handpiece33300%
Maestro DrillMotor, drill, pneumatic32900%
Micro Reciprocating SawDrill, surgical, ent (electric or pneumatic) including handpiece24300%
Micro Oscillating SawDrills, burrs, trephines & accessories (simple, powered)23600%
Core Universal DriverDrill, surgical, ent (electric or pneumatic) including handpiece22600%
Pin ColletInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment22100%
Dual Trigger RotaryInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment21700%
System 6 Sagittal SawInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment20700%
Core Sumex DrillDrill, surgical, ent (electric or pneumatic) including handpiece19100%
Adj Pin Collet 2 0-3 2mmInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment18200%
Micro Drill Medium Straight AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece17800%
Cordless Driver 3Arthroscope17600%
Repair Core Impaction DrillDriver, wire, and bone drill, manual17600%
Angled Long Saber AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece17300.5%
Universal DrillDrill, surgical, ent (electric or pneumatic) including handpiece17000%
System 5 Sagittal SawInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment16200%
Universal High Torque DrillDrill, surgical, ent (electric or pneumatic) including handpiece16000%
Micro DrillDrill, surgical, ent (electric or pneumatic) including handpiece15400%
System 6 Aseptic Housing AssyInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment14800%
Neptune Rover With Smoke Evac And Power PoleApparatus, exhaust, surgical12300.4%
Wire ColletArthroscope10730%
Tps Handpiece CordUnit, operative dental10500%
System 5 Dual Trigger Rotary HandpieceInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment9600%
Impaction Bur GuardInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment9300%
Sagittal Saw AttachmentInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment85640%
Single Trigger RotaryInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment6100%
Sys 6 RecipInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment5900%
Remb Sag SawDrills, burrs, trephines & accessories (simple, powered)4800%

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
ERLDrill, surgical, ent (electric or pneumatic) including handpiece2,84523.2%
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment2,33319%
HBEDrills, burrs, trephines & accessories (simple, powered)2,07316.9%
DZJDriver, wire, and bone drill, manual1,80814.7%
HBBMotor, drill, pneumatic6855.6%
HRXArthroscope5254.3%
HWEInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment3002.4%
FYDApparatus, exhaust, surgical2962.4%
GETMotor, surgical instrument, pneumatic powered2271.8%
MEBPump, infusion, elastomeric2211.8%

Reports by month, five years

011Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

Event type

Death0.1%7
Injury4.9%598
Malfunction94.9%11,659
Other0%2
Not given0.2%20

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 Kalamazoo reports

How many FDA device reports name Stryker Instruments Kalamazoo as manufacturer?

12,286 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Core Impaction Drill (1,178), Micro Sagittal Saw (946), Core Micro Drill (333), Maestro Drill (329) and Micro Reciprocating Saw (243).

Which device types does it report on?

drill, surgical, ent (electric or pneumatic) including handpiece (23.2%), instrument, surgical, orthopedic, dc-powered motor and accessory/attachment (19%), drills, burrs, trephines & accessories (simple, powered) (16.9%) and driver, wire, and bone drill, manual (14.7%).

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.