Devices › Appliance, fixation, spinal interlaminal
Device brand name · Appliance fixation spinal interlaminal
Tsrh Spinal System: medical device reports filed with FDA
457 reports name it, 1997–2022. Manufacturer given most often on reports: Warsaw Orthopedics. Product code KWP.
- 457
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 23.4%
- classified as malfunction
- 46.2% across the product code
- 0.4%
- classified as death, as reported
- 2 reports · not verified by FDA
457 medical device reports received by FDA name the brand "Tsrh Spinal System" (appliance fixation spinal interlaminal); the manufacturer given most often on reports is Warsaw Orthopedics; received from February 1997 to November 2022. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (74.2%), malfunction (23.4%) and other (0.7%); 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 (22.5%), migration or expulsion of device (10.9%) and implant breakage or physical damage (7.7%). The patient problems coded most often are pain, surgical procedure, additional and bacterial infection. 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 | 103 | 22.5% | 29% |
| Migration or expulsion of device | 50 | 10.9% | 7.3% |
| Implant breakage or physical damage | 35 | 7.7% | 1.7% |
| Loose or intermittent connection | 24 | 5.3% | 2.5% |
| Malposition of device | 18 | 3.9% | 1.4% |
| Explanted | 11 | 2.4% | 5.1% |
| Device dislodged or dislocated | 8 | 1.8% | 3.4% |
| Implant, repositioning of | 8 | 1.8% | 0.9% |
| Insufficient device problem information | 8 | 1.8% | 1.7% |
| Implant, removal of | 6 | 1.3% | 0.9% |
| Device remains implanted | 5 | 1.1% | 1.1% |
| Device, or device fragments remain in patient | 5 | 1.1% | 0.5% |
| Device slipped | 4 | 0.9% | 6.6% |
| Fracturea broken bone | 4 | 0.9% | 3.6% |
| Loose | 4 | 0.9% | 1.9% |
| Replace | 4 | 0.9% | 3.2% |
| Device inoperablethe device could not be used | 3 | 0.7% | 0.5% |
| Difficult to removethe device was hard to remove | 3 | 0.7% | 0.9% |
| Failure to align | 3 | 0.7% | 9.2% |
| Detachment of device or device componentpart of the device came off | 2 | 0.4% | 1.1% |
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 | 71 | 15.5% |
| Surgical procedure, additional | 26 | 5.7% |
| Bacterial infectiona bacterial infection | 18 | 3.9% |
| Nonspecific | 11 | 2.4% |
| Cerebrospinal fluid leakage | 10 | 2.2% |
| Device embedded in tissue or plaque | 9 | 2% |
| Nonresorbable materials, unretrieved in body | 8 | 1.8% |
| Neurological deficit/dysfunction | 7 | 1.5% |
| Injurya physical injury | 6 | 1.3% |
| Surgical procedure | 6 | 1.3% |
| Surgical procedure, repeated | 6 | 1.3% |
| Numbnessnumbness | 5 | 1.1% |
| Therapy/non-surgical treatment, additional | 5 | 1.1% |
| Hypersensitivity/allergic reaction | 4 | 0.9% |
| Stenosis | 4 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tsrh Spinal System | Product code KWP | All MAUDE reports |
|---|---|---|---|
| Reports | 457 | 14,609 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 74.2% | 52.6% | 36.2% |
| Classified as malfunction | 23.4% | 46.2% | 62.3% |
| Filed by the manufacturer | 99.3% | 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% |
| 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 Tsrh Spinal System reports
How many FDA reports name Tsrh Spinal System?
457 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (74.2%), malfunction (23.4%) and other (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (22.5%), migration or expulsion of device (10.9%), implant breakage or physical damage (7.7%), loose or intermittent connection (5.3%) and malposition of device (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Tsrh Spinal 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.