Devices › Appliance, fixation, spinal intervertebral body
Device brand name · Spinal fixation system
Tsrh Spinal Fixation System: medical device reports filed with FDA
154 reports name it, 1998–2000. Manufacturer given most often on reports: Medtronic Sofamor Danek Manufacturing. Product code KWQ.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 5 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 2.6%
- classified as malfunction
- 42.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 154 reports that name the brand "Tsrh Spinal Fixation System" (spinal fixation system), received between April 1998 and December 2000; the manufacturer given most often on reports is Medtronic Sofamor Danek Manufacturing. Spellings of one product vary from report to report.
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 (97.4%) and malfunction (2.6%); 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 explanted (84.4%), replace (59.7%) and loose (33.8%). The patient problems coded most often are other (for use when an appropriate patient code cannot be identified), surgical procedure, repeated 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
No report naming Tsrh Spinal Fixation System was received in the five years to August 2026; the latest was received in December 2000.
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 |
|---|---|---|---|
| Explanted | 130 | 84.4% | 11.7% |
| Replace | 92 | 59.7% | 6.1% |
| Loose | 52 | 33.8% | 3.4% |
| Component(s), broken | 19 | 12.3% | 1.2% |
| Other (for use when an appropriate device code cannot be identified) | 16 | 10.4% | 0.7% |
| Device remains implanted | 12 | 7.8% | 3.3% |
| Fracturea broken bone | 7 | 4.5% | 8.4% |
| Breakthe device broke | 6 | 3.9% | 20.8% |
| Migration or expulsion of device | 4 | 2.6% | 6.7% |
| Device, or device fragments remain in patient | 3 | 1.9% | 1% |
| Dislodged | 3 | 1.9% | 0.9% |
| Disengaged | 2 | 1.3% | 0.6% |
| Repair | 2 | 1.3% | 0.1% |
| Sticking | 2 | 1.3% | 0.5% |
| Tears, rips, holes in device, device material | 2 | 1.3% | 0.1% |
| Crackthe device cracked | 1 | 0.6% | 0.3% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.6% | 0.2% |
| Device issuea problem with the device | 1 | 0.6% | 0.7% |
| Device slipped | 1 | 0.6% | 4.1% |
| Entrapment of device | 1 | 0.6% | 0.2% |
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 |
|---|---|---|
| Other (for use when an appropriate patient code cannot be identified) | 96 | 62.3% |
| Surgical procedure, repeated | 93 | 60.4% |
| Painpain, site not specified | 86 | 55.8% |
| Surgical procedure | 39 | 25.3% |
| Therapy/non-surgical treatment, additional | 37 | 24% |
| Failure of implant | 18 | 11.7% |
| Surgical procedure, additional | 18 | 11.7% |
| Identified diagnosis | 4 | 2.6% |
| Dural tear | 3 | 1.9% |
| Nerve damage | 3 | 1.9% |
| Nonresorbable materials, unretrieved in body | 3 | 1.9% |
| Neurological deficit/dysfunction | 2 | 1.3% |
| Numbnessnumbness | 2 | 1.3% |
| Bleeding | 1 | 0.6% |
| Falla fall | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tsrh Spinal Fixation System | Product code KWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 10,584 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 97.4% | 54.1% | 36.2% |
| Classified as malfunction | 2.6% | 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% |
| Venture Anterior Cervical Plate System | 209 | 4 | 0.5% |
| 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% |
| 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 Tsrh Spinal Fixation System reports
How many FDA reports name Tsrh Spinal Fixation System?
154 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 (97.4%) and malfunction (2.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (84.4%), replace (59.7%), loose (33.8%), component(s), broken (12.3%) and other (for use when an appropriate device code cannot be identified) (10.4%). 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 Tsrh Spinal Fixation 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.