Device manufacturer, as written on reports

Warsaw Orthopedic: medical device reports filed with FDA

2,934 reports name it as the manufacturer of the device involved, 2000–2026.

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.

2,934
reports naming it as manufacturer: 0% of all MAUDE reports; 163
reports, 12 months to August 2026: 45 in the 12 months before; 44.3%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

2,934 medical device reports received by FDA give Warsaw Orthopedic as the manufacturer of the device involved, 0% of the MAUDE database, from December 2000 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

163 reports arrived in the 12 months to August 2026, up 262% from 45 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 (53.1%), malfunction (44.3%) and other (1.1%). 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
CD HORIZON Spinal System	Appliance, fixation, spinal interlaminal	1,059	634	0.3%
Manual Orthopedic Surgical Instrument	Orthopedic manual surgical instrument	190	0	0.1%
Vertex Reconstruction System	Appliance, fixation, spinal interlaminal	184	9	0.3%
ATLANTIS Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	137	18	1.6%
Tsrh Spinal System	Appliance, fixation, spinal interlaminal	135	0	0.4%
PRESTIGE Cervical Disc System	Prosthesis, intervertebral disc	81	20	0.4%
Venture Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	69	4	0.5%
Catalyft PL Expandable Interbody System	Intervertebral fusion device with bone graft, lumbar	53	95	0%
Orthopedic Manual Surgical Instrument	Orthopedic manual surgical instrument	23	0	0.2%
CD HORIZON SOLERA Spinal System	Thoracolumbosacral pedicle screw system	22	68	0%
Bryan Cervical Disc System	Prosthesis, intervertebral disc	16	0	0.4%
ELEVATE Spinal System	Intervertebral fusion device with bone graft, lumbar	15	46	0%
Cd Horizon	Appliance, fixation, spinal interlaminal	10	38	0.3%
Unknown Implant	Implant, endosseous, root-form	8	1,454	0%
Verte-Stack Spinal System	Spinal vertebral body replacement device	8	0	0.5%
Metrx	Orthopedic manual surgical instrument	5	3	0%
METRx System	Orthopedic manual surgical instrument	3	267	0.1%
CAPSTONE Spinal System	Intervertebral fusion device with bone graft, lumbar	2	26	0.3%
Infuse Bone Graft	Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction	2	36	0.3%
Infinity	Implant, endosseous, root-form	1	24	2.1%
INFINITY Occipitocervical Upper Thoracic System	Appliance, fixation, spinal interlaminal	1	19	0%
Screwdriver	Screwdriver	1	15	0%
Tsrh Spinal Fixation System	Appliance, fixation, spinal intervertebral body	1	0	0%
Zevo Anterior Cervical Plate System	Appliance, fixation, spinal intervertebral body	1	13	0.6%

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
KWP	Appliance, fixation, spinal interlaminal	1,180	40.2%
KWQ	Appliance, fixation, spinal intervertebral body	447	15.2%
LXH	Orthopedic manual surgical instrument	208	7.1%
HWC	Screw, fixation, bone	171	5.8%
NQP	Posterior metal/polymer spinal system, fusion	166	5.7%
MJO	Prosthesis, intervertebral disc	122	4.2%
MAX	Intervertebral fusion device with bone graft, lumbar	106	3.6%
NKB	Thoracolumbosacral pedicle screw system	86	2.9%
HXX	Screwdriver	68	2.3%
HRS	Plate, fixation, bone	32	1.1%

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

Death0.5%16

Injury53.1%1,559

Malfunction44.3%1,301

Other1.1%33

Not given0.9%25

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

Questions about Warsaw Orthopedic reports

How many FDA device reports name Warsaw Orthopedic as manufacturer?

2,934 reports through August 2026, 163 of them in the latest 12 months.

Which of its brands appear most often?

CD HORIZON Spinal System (1,059), Manual Orthopedic Surgical Instrument (190), Vertex Reconstruction System (184), ATLANTIS Anterior Cervical Plate System (137) and Tsrh Spinal System (135).

Which device types does it report on?

appliance, fixation, spinal interlaminal (40.2%), appliance, fixation, spinal intervertebral body (15.2%), orthopedic manual surgical instrument (7.1%) and screw, fixation, bone (5.8%).

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.