Device manufacturer, as written on reports

Stryker: medical device reports filed with FDA

17,604 reports name it as the manufacturer of the device involved, 1992–2026.

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.

17,604
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,428
reports, 12 months to August 2026: 2,065 in the 12 months before; 31.7%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

17,604 medical device reports received by FDA give Stryker as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,428 reports arrived in the 12 months to August 2026, up 18% from 2,065 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 injury (67.2%), malfunction (31.7%) and death (0.3%). 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
Unknown Apex Pin	Pin, fixation, threaded	378	0	0.5%
Unknown T2 Scn	Rod, fixation, intramedullary and accessories	355	0	0%
Unknown Star Talar Component	Prosthesis, ankle, uncemented, non-constrained	207	0	0%
Stryker	Pump, infusion, elastomeric	189	5	1.3%
Unknown Hoffmann Lrf	Appliance, fixation, nail/blade/plate combination, multiple component	181	0	0%
Unknown T2 Alpha Tibia Nail	Rod, fixation, intramedullary and accessories	175	175	0%
Unknown Talar component	Prosthesis, ankle, semi-constrained, cemented, metal/polymer	171	149	1.1%
Unknown Tibial Component	Prosthesis, ankle, semi-constrained, cemented, metal/polymer	166	200	0%
Unknown Screw	Screw, fixation, bone	164	156	0%
Trochanteric Nail Kit Ti Gamma3 11x180mm X 125	Rod, fixation, intramedullary and accessories	33	0	0.3%
Unknown Kie Product	Rod, fixation, intramedullary and accessories	28	21	0.5%
Unknown Screws	Screw, fixation, bone	10	23	1.7%
Unknown Osteosynthesis Product	Screw, fixation, bone	7	0	0%
Locking Screw	Screw, fixation, bone	4	3	0%
Drill Bit	Bit, drill	2	25	0%
Femoral Head	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	2	11	0%
In Touch Zu	Bed, ac-powered adjustable hospital	2	0	0.1%
3002 Master Boms	Bed, ac-powered adjustable hospital	1	1	1%
Accolade	Implantable pulse generator, pacemaker (non-crt)	1	4	1.5%
Core Impaction Drill	Driver, wire, and bone drill, manual	1	0	0%
Driver	Driver, prosthesis	1	27	0%
Power Pro Ambulance Cot	Stretcher, wheeled	1	0	0.4%
Secure Acute Care Bed 3/01	Bed, ac-powered adjustable hospital	1	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
HRS	Plate, fixation, bone	3,058	17.4%
HSB	Rod, fixation, intramedullary and accessories	2,733	15.5%
HWC	Screw, fixation, bone	2,488	14.1%
LXH	Orthopedic manual surgical instrument	1,442	8.2%
NTG	Prosthesis, ankle, uncemented, non-constrained	1,313	7.5%
KTT	Appliance, fixation, nail/blade/plate combination, multiple component	1,055	6%
KWS	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	763	4.3%
JDW	Pin, fixation, threaded	734	4.2%
HTY	Pin, fixation, smooth	371	2.1%
JWJ	Prosthesis, wrist, 3 part metal-plastic-metal articulation, semi-constrained	211	1.2%

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

Death0.3%58

Injury67.2%11,834

Malfunction31.7%5,583

Other0.2%44

Not given0.5%85

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

Questions about Stryker reports

How many FDA device reports name Stryker as manufacturer?

17,604 reports through August 2026, 2,428 of them in the latest 12 months.

Which of its brands appear most often?

Unknown Apex Pin (378), Unknown T2 Scn (355), Unknown Star Talar Component (207), Stryker (189) and Unknown Hoffmann Lrf (181).

Which device types does it report on?

plate, fixation, bone (17.4%), rod, fixation, intramedullary and accessories (15.5%), screw, fixation, bone (14.1%) and orthopedic manual surgical instrument (8.2%).

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.