Devices › External mandibular fixator and/or distractor
Device brand name · Screw
Level One Cmf: medical device reports filed with FDA
546 reports name it, 2016–2026. Manufacturer given most often on reports: Karl Leibinger Medizintechnik & Kg. Product code MQN.
- 546
- device reports naming the brand
- 0% of all MAUDE reports · about 57 a year
- 32
- reports, 12 months to August 2026
- 44 in the 12 months before
- 2%
- classified as malfunction
- 22.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 546 reports that name the brand "Level One Cmf" (screw), received between November 2016 and July 2026; the manufacturer given most often on reports is Karl Leibinger Medizintechnik & Kg. Spellings of one product vary from report to report.
32 reports arrived in the 12 months to August 2026, down 27% from 44 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 (98%) and malfunction (2%); across all external mandibular fixator and/or distractor reports (product code MQN) death is recorded in 0.2% and malfunction in 22.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (44.5%), osseointegration problem (18.5%) and fracture (10.1%). The patient problems coded most often are impaired healing, device embedded in tissue or plaque and inadequate osseointegration. 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 1,416 reports carrying product code MQN. 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 | 243 | 44.5% | 37.9% |
| Osseointegration problem | 101 | 18.5% | 3.2% |
| Fracturea broken bone | 55 | 10.1% | 4.8% |
| Loss of osseointegration | 20 | 3.7% | 0.4% |
| Device dislodged or dislocated | 9 | 1.6% | 1.1% |
| Failure to osseointegrate | 7 | 1.3% | 0.1% |
| Material twisted/bent | 5 | 0.9% | 0.2% |
| Device-device incompatibility | 4 | 0.7% | 0.9% |
| Component falling | 3 | 0.5% | 0.6% |
| Loosening of implant not related to bone-ingrowth | 3 | 0.5% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 3 | 0.5% | 0.1% |
| Detachment of device component | 2 | 0.4% | 4.4% |
| Insufficient device problem information | 2 | 0.4% | 2.5% |
| Migration or expulsion of device | 2 | 0.4% | 2% |
| Improper or incorrect procedure or method | 1 | 0.2% | 1.1% |
| Installation-related problem | 1 | 0.2% | 0.2% |
| Material deformation | 1 | 0.2% | 0.1% |
| Material integrity problema problem with the device material | 1 | 0.2% | 0% |
| Material split, cut or torn | 1 | 0.2% | 0% |
| Noise, audible | 1 | 0.2% | 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 |
|---|---|---|
| Impaired healingslow healing | 276 | 50.5% |
| Device embedded in tissue or plaque | 52 | 9.5% |
| Inadequate osseointegration | 52 | 9.5% |
| Nonunion/delayed-union bone fracture | 14 | 2.6% |
| Painpain, site not specified | 11 | 2% |
| Foreign body in patientpart of a device left in the patient | 6 | 1.1% |
| Failure of implant | 4 | 0.7% |
| Discomfortdiscomfort | 3 | 0.5% |
| Erosion | 2 | 0.4% |
| Scar tissue | 2 | 0.4% |
| Bruxism | 1 | 0.2% |
| Cancer | 1 | 0.2% |
| Fistula | 1 | 0.2% |
| Malunion of bone | 1 | 0.2% |
| Numbnessnumbness | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Level One Cmf | Product code MQN | All MAUDE reports |
|---|---|---|---|
| Reports | 546 | 1,416 | 26,136,888 |
| Share of that pool | — | 38.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 98% | 75.2% | 36.2% |
| Classified as malfunction | 2% | 22.9% | 62.3% |
| Filed by the manufacturer | 99.8% | 97.9% | 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 MQN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Distraction | 181 | 13 | 0% |
| Spectrum | 157 | 11 | 0.6% |
| Unknown_Fro_Product | 192 | 7 | 0% |
| Level One Thoracic | 265 | 7 | 0% |
| UNK - Screws: CMF | 410 | 280 | 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 Level One Cmf reports
How many FDA reports name Level One Cmf?
546 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 32 in the latest 12 months.
What kinds of events are reported?
injury (98%) and malfunction (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (44.5%), osseointegration problem (18.5%), fracture (10.1%), loss of osseointegration (3.7%) and device dislodged or dislocated (1.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Level One Cmf 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.