Devices › Appliance, fixation, spinal intervertebral body
Device brand name · Appliance fixation spinal intervertebral body
Venture Anterior Cervical Plate System: medical device reports filed with FDA
209 reports name it, 2006–2025. Manufacturer given most often on reports: Warsaw Orthopedic. Product code KWQ.
- 209
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 4
- reports, 12 months to August 2026
- 1 in the 12 months before
- 42.6%
- classified as malfunction
- 42.4% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
209 medical device reports received by FDA name the brand "Venture Anterior Cervical Plate System" (appliance fixation spinal intervertebral body); the manufacturer given most often on reports is Warsaw Orthopedic; received from July 2006 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
4 reports arrived in the 12 months to August 2026, up 300% from 1 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 (42.6%) and other (3.3%); across all appliance, fixation, spinal intervertebral body reports (product code KWQ) death is recorded in 0.6% and malfunction in 42.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration or expulsion of device (22.5%), malposition of device (10%) and break (9.1%). The patient problems coded most often are surgical procedure, additional, dysphagia/ odynophagia and pain. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 10,584 reports carrying product code KWQ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Migration or expulsion of device | 47 | 22.5% | 6.7% |
| Malposition of device | 21 | 10% | 1.8% |
| Breakthe device broke | 19 | 9.1% | 20.8% |
| Implant, repositioning of | 13 | 6.2% | 0.3% |
| Implant, removal of | 11 | 5.3% | 0.9% |
| Device damaged by another device | 7 | 3.3% | 0.5% |
| Device slipped | 6 | 2.9% | 4.1% |
| Explanted | 5 | 2.4% | 11.7% |
| Implant breakage or physical damage | 4 | 1.9% | 0.5% |
| Material fragmentation | 4 | 1.9% | 1.2% |
| Migrationthe device moved from where it was placed | 4 | 1.9% | 4.7% |
| Component missing | 3 | 1.4% | 0.2% |
| Device remains implanted | 3 | 1.4% | 3.3% |
| Disassembly | 3 | 1.4% | 0.4% |
| Insufficient device problem information | 3 | 1.4% | 4.1% |
| Locking mechanism failure | 3 | 1.4% | 0.3% |
| Component falling | 1 | 0.5% | 0.3% |
| Detachment of device or device componentpart of the device came off | 1 | 0.5% | 1.8% |
| Device inoperablethe device could not be used | 1 | 0.5% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.5% | 2.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Surgical procedure, additional | 18 | 8.6% |
| Dysphagia/ odynophagia | 12 | 5.7% |
| Painpain, site not specified | 12 | 5.7% |
| Device embedded in tissue or plaque | 4 | 1.9% |
| Hematomaa collection of blood under the skin or in tissue | 4 | 1.9% |
| Allergic reactionan allergic reaction | 3 | 1.4% |
| Spinal column injury | 3 | 1.4% |
| Fatiguetiredness | 2 | 1% |
| Headachehead pain | 2 | 1% |
| Neurological deficit/dysfunction | 2 | 1% |
| Numbnessnumbness | 2 | 1% |
| Surgical procedure, repeated | 2 | 1% |
| Swellingswelling | 2 | 1% |
| Abscessa collection of pus | 1 | 0.5% |
| Bone fracture(s) | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Venture Anterior Cervical Plate System | Product code KWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 209 | 10,584 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 5 | 6 | 9 |
| Classified as injury | 53.1% | 54.1% | 36.2% |
| Classified as malfunction | 42.6% | 42.4% | 62.3% |
| Filed by the manufacturer | 100% | 95% | 94.9% |
Shares are of reports, not 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."
Other brands with product code KWQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| ATLANTIS Anterior Cervical Plate System | 565 | 18 | 1.6% |
| CD HORIZON Spinal System | 9,787 | 634 | 0.3% |
| Resonate | 227 | 7 | 0.9% |
| Zevo Anterior Cervical Plate System | 157 | 13 | 0.6% |
| Collect No Qas Spine Anterior Stabilis | 269 | 0 | 0% |
| Unknown K2m Product | 269 | 37 | 0% |
| Tsrh Spinal Fixation System | 154 | 0 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Synthes | 470 | 0 | 0.6% |
| Incompass | 170 | 0 | 0% |
| Tsrh Spinal System | 457 | 0 | 0.4% |
| Pivox Oblique Lateral Spinal System | 255 | 5 | 0% |
| Stardrive Screwdriver Shaft T8 105mm | 329 | 43 | 0% |
| Screw | 647 | 0 | 0% |
| Vertex Reconstruction System | 759 | 9 | 0.3% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Venture Anterior Cervical Plate System reports
How many FDA reports name Venture Anterior Cervical Plate System?
209 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.
What kinds of events are reported?
injury (53.1%), malfunction (42.6%) and other (3.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration or expulsion of device (22.5%), malposition of device (10%), break (9.1%), implant, repositioning of (6.2%) and implant, removal of (5.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Venture Anterior Cervical Plate System was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.