Devices › Positioner, tooth, preformed
Device brand name · Positioner tooth preformed
Byte Retainer: medical device reports filed with FDA
1,540 reports name it, 2024–2026. Manufacturer given most often on reports: Straight Smile. Product code KMY.
- 1,540
- device reports naming the brand
- 0% of all MAUDE reports · about 639 a year
- 830
- reports, 12 months to August 2026
- 669 in the 12 months before
- 8.6%
- classified as malfunction
- 9.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,540 medical device reports received by FDA name the brand "Byte Retainer" (positioner tooth preformed); the manufacturer given most often on reports is Straight Smile; received from February 2024 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
830 reports arrived in the 12 months to August 2026, up 24% from 669 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 (91.4%) and malfunction (8.6%); across all positioner, tooth, preformed reports (product code KMY) death is recorded in 0% and malfunction in 9.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are sharp edges (47.1%), patient-device incompatibility (46.2%) and device appears to trigger rejection (38.4%). The patient problems coded most often are deformity/ disfigurement, tooth fracture and laceration(s). 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 1,679 reports carrying product code KMY. 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 |
|---|---|---|---|
| Sharp edges | 726 | 47.1% | 44% |
| Patient-device incompatibilitythe device did not suit the patient | 711 | 46.2% | 42.5% |
| Device appears to trigger rejection | 591 | 38.4% | 35.4% |
| Defective devicethe device was defective | 575 | 37.3% | 34.3% |
| Inadequacy of device shape and/or size | 61 | 4% | 3.8% |
| Unintended movement | 58 | 3.8% | 3.3% |
| Lack of effect | 29 | 1.9% | 1.5% |
| Structural problem | 24 | 1.6% | 1% |
| Crackthe device cracked | 12 | 0.8% | 0.5% |
| Breakthe device broke | 10 | 0.6% | 0.8% |
| Fitting problem | 7 | 0.5% | 0.4% |
| Application program freezes or fails to launch | 4 | 0.3% | 0.2% |
| Material fragmentation | 2 | 0.1% | 0.1% |
| Patient device interaction problem | 2 | 0.1% | 0.2% |
| Pressure problem | 2 | 0.1% | 0.1% |
| Difficult to removethe device was hard to remove | 1 | 0.1% | 0.1% |
| Failure to read input signal | 1 | 0.1% | 0.1% |
| Increase in pressure | 1 | 0.1% | 0.1% |
| Intermittent loss of power | 1 | 0.1% | 0.1% |
| Radiation output problem | 1 | 0.1% | 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 |
|---|---|---|
| Deformity/ disfigurement | 1,034 | 67.1% |
| Tooth fracture | 747 | 48.5% |
| Laceration(s) | 727 | 47.2% |
| Tooth loss | 592 | 38.4% |
| Hypersensitivity/allergic reaction | 587 | 38.1% |
| Necrosisdeath of tissue | 580 | 37.7% |
| Swelling/ edema | 576 | 37.4% |
| Abscessa collection of pus | 574 | 37.3% |
| Tissue breakdown | 156 | 10.1% |
| Painpain, site not specified | 139 | 9% |
| Sensitivity of teeth | 97 | 6.3% |
| Bacterial infectiona bacterial infection | 67 | 4.4% |
| Discomfortdiscomfort | 47 | 3.1% |
| Inflammationinflammation | 42 | 2.7% |
| Loss of range of motion | 38 | 2.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Byte Retainer | Product code KMY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,540 | 1,679 | 26,136,888 |
| Share of that pool | — | 91.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 91.4% | 90.7% | 36.2% |
| Classified as malfunction | 8.6% | 9.2% | 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 KMY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Byte Night Aligners | 6,803 | 1,202 | 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 Byte Retainer reports
How many FDA reports name Byte Retainer?
1,540 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 830 in the latest 12 months.
What kinds of events are reported?
injury (91.4%) and malfunction (8.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
sharp edges (47.1%), patient-device incompatibility (46.2%), device appears to trigger rejection (38.4%), defective device (37.3%) and inadequacy of device shape and/or size (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 Byte Retainer 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.