Devices › Orthosis, spondylolisthesis spinal fixation
Device brand name · Appliance fixation spinal interlaminal
Ti Nut 11mm Width Across Flats: medical device reports filed with FDA
328 reports name it, 2010–2018. Manufacturer given most often on reports: Synthes USA. Product code MNH.
- 328
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 4.3%
- classified as malfunction
- 35% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 328 reports that name the brand "Ti Nut 11mm Width Across Flats" (appliance fixation spinal interlaminal), received between March 2010 and September 2018; the manufacturer given most often on reports is Synthes USA. 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 (95.7%) and malfunction (4.3%); across all orthosis, spondylolisthesis spinal fixation reports (product code MNH) death is recorded in 0% and malfunction in 35%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (19.5%), insufficient device problem information (18.9%) and device operates differently than expected (7.6%). The patient problems coded most often are pain, nonunion/delayed-union bone fracture and stenosis. 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 Ti Nut 11mm Width Across Flats was received in the five years to August 2026; the latest was received in September 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,393 reports carrying product code MNH. 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 | 64 | 19.5% | 21.3% |
| Insufficient device problem information | 62 | 18.9% | 6.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 25 | 7.6% | 3.6% |
| Device slipped | 11 | 3.4% | 6.3% |
| Detachment of device component | 9 | 2.7% | 2.7% |
| Detachment of device or device componentpart of the device came off | 5 | 1.5% | 1.9% |
| Fracturea broken bone | 5 | 1.5% | 5% |
| Difficult to removethe device was hard to remove | 4 | 1.2% | 1% |
| Bent | 3 | 0.9% | 0.7% |
| Failure to adhere or bond | 3 | 0.9% | 0.2% |
| Component falling | 2 | 0.6% | 0.2% |
| Crackthe device cracked | 2 | 0.6% | 0.4% |
| Loose or intermittent connection | 2 | 0.6% | 4.2% |
| Material integrity problema problem with the device material | 2 | 0.6% | 2% |
| Positioning problem | 2 | 0.6% | 0.5% |
| Unintended movement | 2 | 0.6% | 1.8% |
| Burst container or vessel | 1 | 0.3% | 0% |
| Device dislodged or dislocated | 1 | 0.3% | 3.1% |
| Difficult to insertthe device was hard to insert | 1 | 0.3% | 0.6% |
| Inadequacy of device shape and/or size | 1 | 0.3% | 0.1% |
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 | 106 | 32.3% |
| Nonunion/delayed-union bone fracture | 66 | 20.1% |
| Stenosis | 50 | 15.2% |
| Impaired healingslow healing | 24 | 7.3% |
| Discomfortdiscomfort | 20 | 6.1% |
| Bone fracture(s) | 15 | 4.6% |
| Cyst(s) | 15 | 4.6% |
| Irritationirritation | 14 | 4.3% |
| Joint disorder | 6 | 1.8% |
| Failure of implant | 5 | 1.5% |
| Falla fall | 4 | 1.2% |
| Foreign body in patientpart of a device left in the patient | 3 | 0.9% |
| Therapeutic response, decreased | 3 | 0.9% |
| Tissue damage | 3 | 0.9% |
| Nerve damage | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ti Nut 11mm Width Across Flats | Product code MNH | All MAUDE reports |
|---|---|---|---|
| Reports | 328 | 4,393 | 26,136,888 |
| Share of that pool | — | 7.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 95.7% | 64.2% | 36.2% |
| Classified as malfunction | 4.3% | 35% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 MNH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Creo | 427 | 48 | 0.2% |
| Unknown Screw/Rod Construct Accessories | 296 | 0 | 0% |
| Ti Collar With Grooves | 286 | 0 | 0% |
| Xia 3 Titanium Blocker | 340 | 7 | 0% |
| Unknown Screws | 652 | 23 | 1.7% |
| Unknown Mono/Polyaxial Screws | 390 | 0 | 0% |
| Ti Locking Screw | 422 | 0 | 0% |
| Unknown Rods | 183 | 9 | 1.1% |
| Verse Correction Key | 288 | 3 | 0% |
| Mis Single Inner Setscw | 209 | 9 | 0.5% |
| Unknown Cage/Spacer | 280 | 4 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Ti Matrix Locking Cap | 489 | 0 | 1.2% |
| Cd Horizon Solera 5 5/6 0 | 478 | 131 | 0% |
| UNK - Constructs: Plate/Screws | 850 | 9 | 0% |
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 Ti Nut 11mm Width Across Flats reports
How many FDA reports name Ti Nut 11mm Width Across Flats?
328 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 (95.7%) and malfunction (4.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (19.5%), insufficient device problem information (18.9%), device operates differently than expected (7.6%), device slipped (3.4%) and detachment of device component (2.7%). 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 Ti Nut 11mm Width Across Flats 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.