Devices › Holder, head, neurosurgical (skull clamp)
Device brand name · Skull clamps and headrest systems
Mayfield Modified Skull Clamp: medical device reports filed with FDA
2,663 reports name it, 2005–2026. Manufacturer given most often on reports: Integra Lifesciences Oh/USA. Product code HBL.
- 2,663
- device reports naming the brand
- 0% of all MAUDE reports · about 124 a year
- 75
- reports, 12 months to August 2026
- 91 in the 12 months before
- 71.4%
- classified as malfunction
- 64% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
2,663 medical device reports received by FDA name the brand "Mayfield Modified Skull Clamp" (skull clamps and headrest systems); the manufacturer given most often on reports is Integra Lifesciences Oh/USA; received from February 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
75 reports arrived in the 12 months to August 2026, down 18% from 91 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 (71.4%), injury (24.7%) and other (3.6%); 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 (30.8%), unintended movement (26.6%) and mechanical problem (15.4%). The patient problems coded most often are laceration(s), no patient involvement and injury. 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 | 820 | 30.8% | 34.1% |
| Unintended movement | 708 | 26.6% | 20.1% |
| Mechanical problema mechanical problem | 409 | 15.4% | 12.2% |
| Mechanics altered | 122 | 4.6% | 2.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 113 | 4.2% | 4.4% |
| Unstable | 111 | 4.2% | 3.4% |
| Loose or intermittent connection | 107 | 4% | 3.8% |
| Insufficient device problem information | 69 | 2.6% | 2.5% |
| Breakthe device broke | 67 | 2.5% | 4.3% |
| Defective devicethe device was defective | 26 | 1% | 0.6% |
| Decrease in pressure | 21 | 0.8% | 0.7% |
| Material protrusion/extrusion | 21 | 0.8% | 0.4% |
| Physical resistance/sticking | 20 | 0.8% | 0.7% |
| Device contamination with chemical or other material | 15 | 0.6% | 0.3% |
| Improper or incorrect procedure or method | 14 | 0.5% | 0.4% |
| Material integrity problema problem with the device material | 14 | 0.5% | 0.5% |
| Positioning problem | 13 | 0.5% | 0.7% |
| Sticking | 12 | 0.5% | 0.6% |
| Crackthe device cracked | 10 | 0.4% | 0.8% |
| Difficult to open or close | 10 | 0.4% | 0.3% |
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) | 655 | 24.6% |
| No patient involvement | 121 | 4.5% |
| Injurya physical injury | 80 | 3% |
| Hemorrhage/blood loss/bleeding | 18 | 0.7% |
| Tissue damage | 18 | 0.7% |
| Abrasion | 14 | 0.5% |
| Skin tears | 13 | 0.5% |
| Skull fracture | 9 | 0.3% |
| Therapy/non-surgical treatment, additional | 8 | 0.3% |
| Falla fall | 7 | 0.3% |
| Surgical procedure, additional | 7 | 0.3% |
| Head injurya head injury | 6 | 0.2% |
| Needle stick/puncture | 6 | 0.2% |
| Bone fracture(s) | 5 | 0.2% |
| Surgical procedure | 5 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mayfield Modified Skull Clamp | Product code HBL | All MAUDE reports |
|---|---|---|---|
| Reports | 2,663 | 5,835 | 26,136,888 |
| Share of that pool | — | 45.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 24.7% | 28.6% | 36.2% |
| Classified as malfunction | 71.4% | 64% | 62.3% |
| Filed by the manufacturer | 99.6% | 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 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 | 189 | 3 | 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 Modified Skull Clamp reports
How many FDA reports name Mayfield Modified Skull Clamp?
2,663 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 75 in the latest 12 months.
What kinds of events are reported?
malfunction (71.4%), injury (24.7%) and other (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device slipped (30.8%), unintended movement (26.6%), mechanical problem (15.4%), mechanics altered (4.6%) and device operates differently than expected (4.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%), voluntary reports (0.1%) and distributor reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mayfield Modified Skull Clamp 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.