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
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Core Impaction Drill | Driver, wire, and bone drill, manual | 1,178 | 0 | 0% |
| Micro Sagittal Saw | Drills, burrs, trephines & accessories (simple, powered) | 946 | 0 | 0% |
| Core Micro Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 333 | 0 | 0% |
| Maestro Drill | Motor, drill, pneumatic | 329 | 0 | 0% |
| Micro Reciprocating Saw | Drill, surgical, ent (electric or pneumatic) including handpiece | 243 | 0 | 0% |
| Micro Oscillating Saw | Drills, burrs, trephines & accessories (simple, powered) | 236 | 0 | 0% |
| Core Universal Driver | Drill, surgical, ent (electric or pneumatic) including handpiece | 226 | 0 | 0% |
| Pin Collet | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 221 | 0 | 0% |
| Dual Trigger Rotary | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | 217 | 0 | 0% |
| System 6 Sagittal Saw | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 207 | 0 | 0% |
| Core Sumex Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 191 | 0 | 0% |
| Adj Pin Collet 2 0-3 2mm | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | 182 | 0 | 0% |
| Micro Drill Medium Straight Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 178 | 0 | 0% |
| Cordless Driver 3 | Arthroscope | 176 | 0 | 0% |
| Repair Core Impaction Drill | Driver, wire, and bone drill, manual | 176 | 0 | 0% |
| Angled Long Saber Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 173 | 0 | 0.5% |
| Universal Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 170 | 0 | 0% |
| System 5 Sagittal Saw | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | 162 | 0 | 0% |
| Universal High Torque Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 160 | 0 | 0% |
| Micro Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 154 | 0 | 0% |
| System 6 Aseptic Housing Assy | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 148 | 0 | 0% |
| Neptune Rover With Smoke Evac And Power Pole | Apparatus, exhaust, surgical | 123 | 0 | 0.4% |
| Wire Collet | Arthroscope | 107 | 3 | 0% |
| Tps Handpiece Cord | Unit, operative dental | 105 | 0 | 0% |
| System 5 Dual Trigger Rotary Handpiece | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | 96 | 0 | 0% |
| Impaction Bur Guard | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 93 | 0 | 0% |
| Sagittal Saw Attachment | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 85 | 64 | 0% |
| Single Trigger Rotary | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 61 | 0 | 0% |
| Sys 6 Recip | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | 59 | 0 | 0% |
| Remb Sag Saw | Drills, burrs, trephines & accessories (simple, powered) | 48 | 0 | 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 |
|---|---|---|---|
| ERL | Drill, surgical, ent (electric or pneumatic) including handpiece | 2,845 | 23.2% |
| KIJ | Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment | 2,333 | 19% |
| HBE | Drills, burrs, trephines & accessories (simple, powered) | 2,073 | 16.9% |
| DZJ | Driver, wire, and bone drill, manual | 1,808 | 14.7% |
| HBB | Motor, drill, pneumatic | 685 | 5.6% |
| HRX | Arthroscope | 525 | 4.3% |
| HWE | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 300 | 2.4% |
| FYD | Apparatus, exhaust, surgical | 296 | 2.4% |
| GET | Motor, surgical instrument, pneumatic powered | 227 | 1.8% |
| MEB | Pump, infusion, elastomeric | 221 | 1.8% |
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
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.