Devices › Drills, burrs, trephines & accessories (compound, powered)
Device brand name · Drills burrs trephines accessories compound powered
Codman: medical device reports filed with FDA
183 reports name it, 1996–2025. Manufacturer given most often on reports: Codman & Shurtleff. Product code HBF.
- 183
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 6 in the 12 months before
- 57.9%
- classified as malfunction
- 48.6% across the product code
- 1.6%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 183 reports that name the brand "Codman" (drills burrs trephines accessories compound powered), received between October 1996 and April 2025; the manufacturer given most often on reports is Codman & Shurtleff. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 6 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 (57.9%), injury (36.1%) and other (2.7%); across all drills, burrs, trephines & accessories (compound, powered) reports (product code HBF) death is recorded in 0.1% and malfunction in 48.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are explanted (8.2%), break (4.9%) and replace (4.9%). The patient problems coded most often are surgical procedure, therapy/non-surgical treatment, additional 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
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 2,732 reports carrying product code HBF. 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 |
|---|---|---|---|
| Explanted | 15 | 8.2% | 0% |
| Breakthe device broke | 9 | 4.9% | 4.5% |
| Replace | 9 | 4.9% | 0.8% |
| Device remains activated | 8 | 4.4% | 17.6% |
| Device issuea problem with the device | 7 | 3.8% | 1.8% |
| Device, or device fragments remain in patient | 5 | 2.7% | 0.1% |
| Tip breakage | 5 | 2.7% | 0.1% |
| Component(s), broken | 3 | 1.6% | 0.3% |
| Fracturea broken bone | 3 | 1.6% | 1% |
| Malfunction | 3 | 1.6% | 0.6% |
| Plunge | 3 | 1.6% | 3.4% |
| Detachment of device component | 2 | 1.1% | 0.6% |
| Device or device fragments location unknown | 2 | 1.1% | 0% |
| Difficult to removethe device was hard to remove | 2 | 1.1% | 1.4% |
| Mechanical problema mechanical problem | 2 | 1.1% | 2.8% |
| Migration or expulsion of device | 2 | 1.1% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 1.1% | 3.6% |
| Pressure sensor failure | 2 | 1.1% | 0.1% |
| Tube(s), defective | 2 | 1.1% | 0% |
| Arcing | 1 | 0.5% | 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 |
|---|---|---|
| Surgical procedure | 11 | 6% |
| Therapy/non-surgical treatment, additional | 11 | 6% |
| Foreign body, removal of | 7 | 3.8% |
| Surgical procedure, repeated | 7 | 3.8% |
| Dural tear | 6 | 3.3% |
| Bleeding | 4 | 2.2% |
| Nonresorbable materials, unretrieved in body | 4 | 2.2% |
| Surgical procedure, additional | 4 | 2.2% |
| Failure of implant | 3 | 1.6% |
| Hospitalization required | 3 | 1.6% |
| Neck painneck pain | 3 | 1.6% |
| Painpain, site not specified | 3 | 1.6% |
| Bone fracture(s) | 2 | 1.1% |
| Burn(s)a burn | 2 | 1.1% |
| Hemostasis | 2 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Codman | Product code HBF | All MAUDE reports |
|---|---|---|---|
| Reports | 183 | 2,732 | 26,136,888 |
| Share of that pool | — | 6.7% | 0% |
| Classified as death, per 1,000 reports | 16 | 1 | 9 |
| Classified as injury | 36.1% | 49.5% | 36.2% |
| Classified as malfunction | 57.9% | 48.6% | 62.3% |
| Filed by the manufacturer | 2.7% | 90.8% | 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 HBF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Codman Dispos Perforator | 676 | 21 | 0% |
| Codman Disposable Perforator | 647 | 0 | 0.2% |
| Easydrill Perforator | 417 | 37 | 0% |
| Mayfield | 189 | 3 | 0% |
| Mayfield Modified Skull Clamp | 2,663 | 75 | 0% |
| Midas Rex | 688 | 591 | 0% |
| Perforator Driver W/Hudson End | 695 | 0 | 0% |
| Drill Bit | 158 | 25 | 0% |
| Hakim Programmable Valve | 693 | 9 | 0.9% |
| Midas Rex Legend | 952 | 356 | 0% |
| Motor Mr8 Electric | 325 | 4 | 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 Codman reports
How many FDA reports name Codman?
183 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 (57.9%), injury (36.1%) and other (2.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (8.2%), break (4.9%), replace (4.9%), device remains activated (4.4%) and device issue (3.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (35.5%) and manufacturer reports (2.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Codman 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.