Devices › Appliance, fixation, spinal interlaminal
Device brand name · Appliance fixation spinal interlaminal
INFINITY Occipitocervical Upper Thoracic System: medical device reports filed with FDA
156 reports name it, 2020–2026. Manufacturer given most often on reports: Mdt Sofamor Danek Puerto Rico Mfg. Product code KWP.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 19
- reports, 12 months to August 2026
- 29 in the 12 months before
- 53.8%
- classified as malfunction
- 46.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
156 medical device reports received by FDA name the brand "INFINITY Occipitocervical Upper Thoracic System" (appliance fixation spinal interlaminal); the manufacturer given most often on reports is Mdt Sofamor Danek Puerto Rico Mfg; received from February 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
19 reports arrived in the 12 months to August 2026, down 34% from 29 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 (53.8%) and injury (46.2%); 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 material deformation (32.7%), migration (12.2%) and device dislodged or dislocated (11.5%). The patient problems coded most often are paralysis, neck pain and injury. 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 |
|---|---|---|---|
| Material deformation | 51 | 32.7% | 2.7% |
| Migrationthe device moved from where it was placed | 19 | 12.2% | 1.9% |
| Device dislodged or dislocated | 18 | 11.5% | 3.4% |
| Breakthe device broke | 14 | 9% | 29% |
| Loosening of implant not related to bone-ingrowth | 7 | 4.5% | 1.8% |
| Mechanical jam | 6 | 3.8% | 0.4% |
| Mechanics altered | 6 | 3.8% | 0.5% |
| Device damaged by another device | 2 | 1.3% | 0.7% |
| Expulsion | 2 | 1.3% | 0.1% |
| Failure to align | 2 | 1.3% | 9.2% |
| Defective component | 1 | 0.6% | 0% |
| Device handling problem | 1 | 0.6% | 0% |
| Failure to advance | 1 | 0.6% | 0.1% |
| Fracturea broken bone | 1 | 0.6% | 3.6% |
| Malposition of device | 1 | 0.6% | 1.4% |
| Manufacturing, packaging or shipping problem | 1 | 0.6% | 0% |
| Material too rigid or stiff | 1 | 0.6% | 0% |
| Material twisted/bent | 1 | 0.6% | 0.4% |
| Migration or expulsion of device | 1 | 0.6% | 7.3% |
| Positioning failure | 1 | 0.6% | 0% |
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 |
|---|---|---|
| Paralysis | 11 | 7.1% |
| Neck painneck pain | 7 | 4.5% |
| Injurya physical injury | 6 | 3.8% |
| Hemorrhage/blood loss/bleeding | 4 | 2.6% |
| Burning sensationa burning feeling | 3 | 1.9% |
| Disability | 3 | 1.9% |
| Neurological deficit/dysfunction | 3 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 1.3% |
| Device embedded in tissue or plaque | 2 | 1.3% |
| Painpain, site not specified | 2 | 1.3% |
| Arteriosclerosis/ atherosclerosis | 1 | 0.6% |
| Blood loss | 1 | 0.6% |
| Disc impingement | 1 | 0.6% |
| Discomfortdiscomfort | 1 | 0.6% |
| Inadequate osseointegration | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | INFINITY Occipitocervical Upper Thoracic System | Product code KWP | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 14,609 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 46.2% | 52.6% | 36.2% |
| Classified as malfunction | 53.8% | 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% |
| Vertex Reconstruction System | 759 | 9 | 0.3% |
| Cd Horizon | 388 | 38 | 0.3% |
| Tsrh Spinal System | 457 | 0 | 0.4% |
| ATLANTIS Anterior Cervical Plate System | 565 | 18 | 1.6% |
| 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 INFINITY Occipitocervical Upper Thoracic System reports
How many FDA reports name INFINITY Occipitocervical Upper Thoracic System?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 19 in the latest 12 months.
What kinds of events are reported?
malfunction (53.8%) and injury (46.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (32.7%), migration (12.2%), device dislodged or dislocated (11.5%), break (9%) and loosening of implant not related to bone-ingrowth (4.5%). 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 INFINITY Occipitocervical Upper Thoracic 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.