Devices › Screw, fixation, bone
Device brand name · Ultratine forehead 3 5
Microaire: medical device reports filed with FDA
176 reports name it, 1996–2018. Manufacturer given most often on reports: Microaire Surgical Instruments. Product code HWC.
- 176
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 67.6%
- classified as malfunction
- 30.8% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
176 medical device reports received by FDA name the brand "Microaire" (ultratine forehead 3 5); the manufacturer given most often on reports is Microaire Surgical Instruments; received from August 1996 to November 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 malfunction (67.6%), injury (31.3%) and death (0.6%); across all screw, fixation, bone reports (product code HWC) death is recorded in 0.1% and malfunction in 30.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (39.2%), crack (5.7%) and out-of-box failure (4%). The patient problems coded most often are no patient involvement, device embedded in tissue or plaque and foreign body, removal of. 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 Microaire was received in the five years to August 2026; the latest was received in November 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 58,946 reports carrying product code HWC. 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 | 69 | 39.2% | 26.4% |
| Crackthe device cracked | 10 | 5.7% | 0.5% |
| Out-of-box failure | 7 | 4% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 3.4% | 1.8% |
| Fitting problem | 5 | 2.8% | 0.4% |
| Fracturea broken bone | 5 | 2.8% | 4.2% |
| Device damaged prior to usethe device was damaged before use | 4 | 2.3% | 0.1% |
| Insufficient device problem information | 4 | 2.3% | 4.3% |
| Burst container or vessel | 3 | 1.7% | 0% |
| Detachment of device component | 3 | 1.7% | 1.4% |
| Device slipped | 3 | 1.7% | 1.9% |
| Bent | 2 | 1.1% | 0.5% |
| Collapse | 2 | 1.1% | 0% |
| Component falling | 2 | 1.1% | 0.2% |
| Device dislodged or dislocated | 2 | 1.1% | 1.8% |
| Device, or device fragments remain in patient | 2 | 1.1% | 0.9% |
| Loose or intermittent connection | 2 | 1.1% | 0.6% |
| Metal shedding debris | 2 | 1.1% | 0.2% |
| Packaging problem | 2 | 1.1% | 0.2% |
| Activation, positioning or separation problem | 1 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 12 | 6.8% |
| Device embedded in tissue or plaque | 4 | 2.3% |
| Foreign body, removal of | 4 | 2.3% |
| Failure of implant | 3 | 1.7% |
| Burn(s)a burn | 2 | 1.1% |
| Injurya physical injury | 2 | 1.1% |
| Nonresorbable materials, unretrieved in body | 2 | 1.1% |
| Therapy/non-surgical treatment, additional | 2 | 1.1% |
| Abscessa collection of pus | 1 | 0.6% |
| Bone fracture(s) | 1 | 0.6% |
| Capsular contracturescar tissue tightening around an implant | 1 | 0.6% |
| Deaththe patient died; cause not stated by this term | 1 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.6% |
| Itching sensation | 1 | 0.6% |
| Malaisegeneral feeling of being unwell | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Microaire | Product code HWC | All MAUDE reports |
|---|---|---|---|
| Reports | 176 | 58,946 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 6 | 1 | 9 |
| Classified as injury | 31.3% | 67.2% | 36.2% |
| Classified as malfunction | 67.6% | 30.8% | 62.3% |
| Filed by the manufacturer | 97.2% | 97.3% | 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 HWC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| UNK - Screws: Trauma | 3,576 | 288 | 0% |
| UNK - Screws: Locking | 2,331 | 98 | 0% |
| Unk - Screws Cortex | 889 | 16 | 0% |
| Unknown Screw | 1,222 | 156 | 0% |
| Screw | 647 | 0 | 0% |
| UNK - Screws: Nail Distal Locking | 444 | 12 | 0.2% |
| Unknown Screws | 652 | 23 | 1.7% |
| UNK - Screws: CMF | 410 | 280 | 0% |
| UNK - Screws: Locking: Trauma | 276 | 34 | 0% |
| Unk - Screws 3 5 Mm Cortex | 220 | 33 | 0% |
| Unk - Screws Nail Locking | 211 | 19 | 0% |
| UNK - Screws: 2.7 mm VA Locking | 204 | 22 | 0% |
| Unk - Screws Cannulated | 190 | 9 | 0.5% |
| Unk - Screws | 256 | 0 | 0% |
| Locking Screw | 241 | 3 | 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 Microaire reports
How many FDA reports name Microaire?
176 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?
malfunction (67.6%), injury (31.3%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (39.2%), crack (5.7%), out-of-box failure (4%), device operates differently than expected (3.4%) and fitting problem (2.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.2%) and voluntary reports (1.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Microaire 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.