Holder, head, neurosurgical (skull clamp): medical device reports filed with FDA

5,835 reports carry this product code, 1992–2026; 11 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,835
reports with this product code: 0% of all MAUDE reports; 203
reports, 12 months to August 2026: 243 in the 12 months before; 64%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code HBL is FDA's classification for "Holder, head, neurosurgical (skull clamp)" (neurology panel), a class 2 device. 5,835 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

203 reports arrived in the 12 months to August 2026, down 16% from 243 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 (64%), injury (28.6%) and other (6.2%). 11 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Mayfield Modified Skull Clamp	2,656	75	0%	71.4%
Mayfield Composite Series Skull Clamp	645	33	0.2%	75.5%
Mayfield Infinity Skull Clamp	238	7	0%	65.7%
Mayfield Triad Skull Clamp	234	1	0%	71.6%
DORO Skull Clamp	203	62	0%	12.8%
Mayfield	179	3	0%	40.2%
Mayfield Infinity Xr2 Skull Clamp	179	3	0.6%	80%
Mayfield 2000 Skull Clamp	170	0	0%	82.9%
Mayfield Ultra Base Unit	46	8	0%	94.5%
Ni	3	1,587	1.8%	29.5%
CUSA EXcel 36kHz Straight Handpiece	1	4	0.3%	94.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Integra Lifesciences Oh/USA	3,973	68.1%
Integra Lifesciences	515	8.8%
Integra Lifesciences Ireland	8	0.1%
Depuy Spine	2	0%
Maquet	2	0%
Integra Neurosciences Pr	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%5

Injury28.6%1,669

Malfunction64%3,737

Other6.2%363

Not given1%61

Who filed

Manufacturer report92.4%5,390

Voluntary report1.8%105

User facility report0%0

Distributor report1.6%96

Not given4.2%244

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device slipped	1,987	34.1%
Unintended movement	1,173	20.1%
Mechanical problema mechanical problem	713	12.2%
Device operates differently than expectedthe device behaved unexpectedly	256	4.4%
Breakthe device broke	248	4.3%
Loose or intermittent connection	222	3.8%
Unstable	198	3.4%
Mechanics altered	166	2.8%
Insufficient device problem information	146	2.5%
Loose	56	1%
Device handling problem	46	0.8%
Crackthe device cracked	44	0.8%
Detachment of device component	44	0.8%
Positioning problem	43	0.7%
Physical resistance/sticking	42	0.7%
Decrease in pressure	39	0.7%
Defective devicethe device was defective	35	0.6%
Replace	33	0.6%
Sticking	33	0.6%
Device dislodged or dislocated	31	0.5%

Questions about holder, head, neurosurgical (skull clamp) reports

What is product code HBL?

FDA's classification code for "Holder, head, neurosurgical (skull clamp)", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,835 reports through August 2026, 203 of them in the latest 12 months.

Which brands appear most often?

Mayfield Modified Skull Clamp (2,656), Mayfield Composite Series Skull Clamp (645), Mayfield Infinity Skull Clamp (238), Mayfield Triad Skull Clamp (234) and DORO Skull Clamp (203). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.