Devices › Appliance, fixation, spinal interlaminal
Device brand name · Appliance fixation spinal interlaminal
Vertex Reconstruction System: medical device reports filed with FDA
759 reports name it, 2006–2026. Manufacturer given most often on reports: Warsaw Orthopedics. Product code KWP.
- 759
- device reports naming the brand
- 0% of all MAUDE reports · about 37 a year
- 9
- reports, 12 months to August 2026
- 11 in the 12 months before
- 51.1%
- classified as malfunction
- 46.2% across the product code
- 0.3%
- classified as death, as reported
- 2 reports · not verified by FDA
759 medical device reports received by FDA name the brand "Vertex Reconstruction System" (appliance fixation spinal interlaminal); the manufacturer given most often on reports is Warsaw Orthopedics; received from April 2006 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
9 reports arrived in the 12 months to August 2026, down 18% from 11 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 (51.1%), injury (47.8%) and death (0.3%); across all appliance, fixation, spinal interlaminal reports (product code KWP) death is recorded in 0.3% and malfunction in 46.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (38.3%), migration or expulsion of device (13.2%) and implant breakage or physical damage (6.3%). The patient problems coded most often are pain, device embedded in tissue or plaque and surgical procedure, additional. 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 14,609 reports carrying product code KWP. 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 |
|---|---|---|---|
| Breakthe device broke | 291 | 38.3% | 29% |
| Migration or expulsion of device | 100 | 13.2% | 7.3% |
| Implant breakage or physical damage | 48 | 6.3% | 1.7% |
| Failure to align | 26 | 3.4% | 9.2% |
| Malposition of device | 24 | 3.2% | 1.4% |
| Material deformation | 21 | 2.8% | 2.7% |
| Loose or intermittent connection | 18 | 2.4% | 2.5% |
| Device slipped | 15 | 2% | 6.6% |
| Disassembly | 13 | 1.7% | 0.6% |
| Implant, repositioning of | 13 | 1.7% | 0.9% |
| Implant, removal of | 11 | 1.4% | 0.9% |
| Device dislodged or dislocated | 10 | 1.3% | 3.4% |
| Insufficient device problem information | 10 | 1.3% | 1.7% |
| Loosening of implant not related to bone-ingrowth | 10 | 1.3% | 1.8% |
| Migrationthe device moved from where it was placed | 10 | 1.3% | 1.9% |
| Detachment of device or device componentpart of the device came off | 9 | 1.2% | 1.1% |
| Explanted | 6 | 0.8% | 5.1% |
| Mechanical problema mechanical problem | 6 | 0.8% | 1.4% |
| Crackthe device cracked | 2 | 0.3% | 0.3% |
| Detachment of device component | 2 | 0.3% | 2.3% |
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 |
|---|---|---|
| Painpain, site not specified | 39 | 5.1% |
| Device embedded in tissue or plaque | 31 | 4.1% |
| Surgical procedure, additional | 23 | 3% |
| Neck painneck pain | 15 | 2% |
| Neurological deficit/dysfunction | 14 | 1.8% |
| Injurya physical injury | 11 | 1.4% |
| Post operative wound infection | 10 | 1.3% |
| Failure of implant | 9 | 1.2% |
| Bone fracture(s) | 7 | 0.9% |
| Discomfortdiscomfort | 7 | 0.9% |
| Paralysis | 6 | 0.8% |
| Numbnessnumbness | 5 | 0.7% |
| Cardiac arrestthe heart stopped | 4 | 0.5% |
| Hematomaa collection of blood under the skin or in tissue | 4 | 0.5% |
| Spinal cord injury | 4 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vertex Reconstruction System | Product code KWP | All MAUDE reports |
|---|---|---|---|
| Reports | 759 | 14,609 | 26,136,888 |
| Share of that pool | — | 5.2% | 0% |
| Classified as death, per 1,000 reports | 3 | 3 | 9 |
| Classified as injury | 47.8% | 52.6% | 36.2% |
| Classified as malfunction | 51.1% | 46.2% | 62.3% |
| Filed by the manufacturer | 100% | 98.3% | 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 KWP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CD HORIZON Spinal System | 9,787 | 634 | 0.3% |
| Cd Horizon | 388 | 38 | 0.3% |
| Tsrh Spinal System | 457 | 0 | 0.4% |
| ATLANTIS Anterior Cervical Plate System | 565 | 18 | 1.6% |
| INFINITY Occipitocervical Upper Thoracic System | 156 | 19 | 0% |
| Ti Nut 11mm Width Across Flats | 328 | 0 | 0% |
| Ni | 32,939 | 1,587 | 1.8% |
| Collect No Qas Spine Anterior Stabilis | 269 | 0 | 0% |
| Ti Collar With Grooves | 286 | 0 | 0% |
| Expedium | 361 | 235 | 0% |
| Ti Locking Screw | 422 | 0 | 0% |
| CD HORIZON SOLERA Spinal System | 320 | 68 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Venture Anterior Cervical Plate System | 209 | 4 | 0.5% |
| Infinity | 193 | 24 | 2.1% |
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 Vertex Reconstruction System reports
How many FDA reports name Vertex Reconstruction System?
759 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
malfunction (51.1%), injury (47.8%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (38.3%), migration or expulsion of device (13.2%), implant breakage or physical damage (6.3%), failure to align (3.4%) and malposition of device (3.2%). 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 Vertex Reconstruction 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.