Devices › Holder, head, neurosurgical (skull clamp)
Device brand name · Skull clamp
Mayfield: medical device reports filed with FDA
189 reports name it, 1992–2026. Manufacturer given most often on reports: Integra Lifesciences. Product code HBL.
- 189
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 3
- reports, 12 months to August 2026
- 0 in the 12 months before
- 40.2%
- classified as malfunction
- 64% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
189 medical device reports received by FDA name the brand "Mayfield" (skull clamp); the manufacturer given most often on reports is Integra Lifesciences; received from July 1992 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
3 reports arrived in the 12 months to August 2026, with 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 other (40.7%), malfunction (40.2%) and injury (11.1%); across all holder, head, neurosurgical (skull clamp) reports (product code HBL) death is recorded in 0.1% and malfunction in 64%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device slipped (28%), other (for use when an appropriate device code cannot be identified) (5.8%) and loose (5.3%). The patient problems coded most often are laceration(s), therapy/non-surgical treatment, additional and surgical procedure. 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 5,835 reports carrying product code HBL. 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 |
|---|---|---|---|
| Device slipped | 53 | 28% | 34.1% |
| Other (for use when an appropriate device code cannot be identified) | 11 | 5.8% | 0.5% |
| Loose | 10 | 5.3% | 1% |
| Decrease in pressure | 6 | 3.2% | 0.7% |
| Locking mechanism failure | 6 | 3.2% | 0.3% |
| Device maintenance issue | 5 | 2.6% | 0.2% |
| Material separation | 4 | 2.1% | 0.4% |
| Replace | 4 | 2.1% | 0.6% |
| Device issuea problem with the device | 3 | 1.6% | 0.2% |
| Breakthe device broke | 2 | 1.1% | 4.3% |
| Defective component | 2 | 1.1% | 0.2% |
| Difficult to position | 2 | 1.1% | 0.3% |
| Lockout mechanism failure | 2 | 1.1% | 0% |
| Mechanical problema mechanical problem | 2 | 1.1% | 12.2% |
| Detachment of device component | 1 | 0.5% | 0.8% |
| Device, removal of (non-implant) | 1 | 0.5% | 0.1% |
| Disengaged | 1 | 0.5% | 0.1% |
| Failure to align | 1 | 0.5% | 0% |
| Material integrity problema problem with the device material | 1 | 0.5% | 0.5% |
| Method, improper/incorrect | 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 |
|---|---|---|
| Laceration(s) | 82 | 43.4% |
| Therapy/non-surgical treatment, additional | 14 | 7.4% |
| Surgical procedure | 13 | 6.9% |
| Surgical procedure, additional | 10 | 5.3% |
| Dural tear | 8 | 4.2% |
| Head injurya head injury | 4 | 2.1% |
| Injurya physical injury | 4 | 2.1% |
| Skull fracture | 4 | 2.1% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.6% |
| Bleeding | 2 | 1.1% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.1% |
| Surgical procedure aborted/stopped | 2 | 1.1% |
| Swellingswelling | 2 | 1.1% |
| Abrasion | 1 | 0.5% |
| Cut(s) | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mayfield | Product code HBL | All MAUDE reports |
|---|---|---|---|
| Reports | 189 | 5,835 | 26,136,888 |
| Share of that pool | — | 3.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 11.1% | 28.6% | 36.2% |
| Classified as malfunction | 40.2% | 64% | 62.3% |
| Filed by the manufacturer | 42.3% | 92.4% | 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 HBL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mayfield Modified Skull Clamp | 2,663 | 75 | 0% |
| Mayfield Composite Series Skull Clamp | 646 | 33 | 0.2% |
| Mayfield Infinity Skull Clamp | 239 | 7 | 0% |
| Mayfield Triad Skull Clamp | 236 | 1 | 0% |
| DORO Skull Clamp | 203 | 62 | 0% |
| Mayfield Infinity Xr2 Skull Clamp | 180 | 3 | 0.6% |
| Mayfield 2000 Skull Clamp | 170 | 0 | 0% |
| Mayfield Ultra Base Unit | 495 | 8 | 0% |
| Ni | 32,939 | 1,587 | 1.8% |
| CUSA EXcel 36kHz Straight Handpiece | 313 | 4 | 0.3% |
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 Mayfield reports
How many FDA reports name Mayfield?
189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
other (40.7%), malfunction (40.2%) and injury (11.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device slipped (28%), other (for use when an appropriate device code cannot be identified) (5.8%), loose (5.3%), decrease in pressure (3.2%) and locking mechanism failure (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (42.3%) and voluntary reports (4.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mayfield 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.