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FDA product code KWP · class 2 · Orthopedic
Appliance, fixation, spinal interlaminal: medical device reports filed with FDA
14,609 reports carry this product code, 1993–2026; 30 brands with a page.
- 14,609
- reports with this product code
- 0.1% of all MAUDE reports
- 607
- reports, 12 months to August 2026
- 495 in the 12 months before
- 46.2%
- classified as malfunction
- 62.3% across all reports
- 0.3%
- classified as death, as reported
- 0.9% across all reports
Product code KWP is FDA's classification for "Appliance, fixation, spinal interlaminal" (orthopedic panel), a class 2 device. 14,609 medical device reports carry this product code, 0.1% of the MAUDE database, from November 1993 to August 2026.
607 reports arrived in the 12 months to August 2026, up 23% from 495 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 (52.6%), malfunction (46.2%) and other (0.5%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Mdt Sofamor Danek Puerto Rico Mfg | 2,917 | 20% |
| Warsaw Orthopedics | 1,903 | 13% |
| Medtronic Sofamor Danek | 1,289 | 8.8% |
| Warsaw Orthopedic | 1,180 | 8.1% |
| Medtronic Sofamor Danek USA | 714 | 4.9% |
| Synthes USA | 662 | 4.5% |
| Medos International S Rl Ch | 381 | 2.6% |
| Zimmer Biomet Spine | 332 | 2.3% |
| Stryker Spine-France | 312 | 2.1% |
| Zimmer Spine | 310 | 2.1% |
| Stryker Spine Bordeaux | 272 | 1.9% |
| Mdt Puerto Rico Operations Med Rel | 228 | 1.6% |
| Synthes Brandywine | 201 | 1.4% |
| Abbott Spine | 173 | 1.2% |
| Depuy Spine | 164 | 1.1% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 4,231 | 29% |
| Failure to align | 1,346 | 9.2% |
| Migration or expulsion of device | 1,067 | 7.3% |
| Device slipped | 970 | 6.6% |
| Explanted | 752 | 5.1% |
| Fracturea broken bone | 524 | 3.6% |
| Device dislodged or dislocated | 503 | 3.4% |
| Replace | 471 | 3.2% |
| Material deformation | 400 | 2.7% |
| Loose or intermittent connection | 368 | 2.5% |
| Detachment of device component | 341 | 2.3% |
| Loose | 279 | 1.9% |
| Migrationthe device moved from where it was placed | 278 | 1.9% |
| Loosening of implant not related to bone-ingrowth | 263 | 1.8% |
| Implant breakage or physical damage | 254 | 1.7% |
| Insufficient device problem information | 243 | 1.7% |
| Mechanical problema mechanical problem | 206 | 1.4% |
| Malposition of device | 198 | 1.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 163 | 1.1% |
| Device remains implanted | 158 | 1.1% |
Questions about appliance, fixation, spinal interlaminal reports
What is product code KWP?
FDA's classification code for "Appliance, fixation, spinal interlaminal", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
14,609 reports through August 2026, 607 of them in the latest 12 months.
Which brands appear most often?
CD HORIZON Spinal System (6,202), Vertex Reconstruction System (704), Cd Horizon (362), Tsrh Spinal System (325) and ATLANTIS Anterior Cervical Plate System (189). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.