PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Holder, Head, Neurosurgical (Skull Clamp)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §882.4460 (Neurology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Holder, Head, Neurosurgical LIGHT-BOOK · MAUDE

#295 of 1000 · 5,826 reports · 1992–2026

  • BOOK 5,826 reports
  • RANK #295 of 1000
  • DEATH 5 death-typed
  • INJ 1,666 injury-typed
  • MALF 3,733 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 1,028
  • PHOTO Extended Depth Of Foc…

Nearest event-volume peer: Extended Depth Of Focus Intraocular Lens (10 report gap)

Holder, Head, Neurosurgical (Skull Clamp) sits #295 of 1000 among tracked device types with 5,826 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Holder, Head, Neurosurgical carries 28.6% INJURY-coded reports, 1.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 28.6% corpus 30.3% · below corpus mean (-1.7 pp)
  • MALF 64.1% corpus 64.8% · below corpus mean (-0.8 pp)

Lead product-problem code Device Slipped is 34% of coded problems · Lead manufacturer INTEGRA LIFESCIENCES CORPORATION OH/USA accounts for 100% of manufacturer-tagged reports · Top event location I is 50% of location-tagged rows .

Holder, Head, Neurosurgical in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Holder, Head, Neurosurgical (Skull Clamp) carries 5,826 MAUDE reports, ranked #295 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 3,733 (64.1%)
Injury 1,666 (28.6%)
Other 361 (6.2%)
61 (1.0%)
Death 5 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

4,412 (74.5%)
Other 1,009 (17.0%)
Required Intervention 353 (6.0%)
R 107 (1.8%)
Hospitalization 15 (0.3%)
Disability 7 (0.1%)
Life Threatening 7 (0.1%)
Death 5 (0.1%)
O 3 (0.1%)
S 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Device Slipped 1,983
Unintended Movement 1,173
Mechanical Problem 716
Device Operates Differently Than Expected 257
Break 248
Loose or Intermittent Connection 227
Unstable 203
Mechanics Altered 168
Insufficient Device Problem Information 148
Adverse Event Without Identified Device or Use Problem 140
Use of Device Problem 78
Unknown (for use when the device problem is not known) 63
Loose 58
No Apparent Adverse Event 55
Device Handling Problem 48
Detachment Of Device Component 47
Positioning Problem 46
Crack 45
Decrease in Pressure 42
Physical Resistance/Sticking 42

Yearly Trend

92
1992: 6
93
1993: 3
94
1994: 3
96
1996: 4
97
1997: 11
98
1998: 34
99
1999: 13
00
2000: 36
01
2001: 38
02
2002: 45
03
2003: 49
04
2004: 41
05
2005: 73
06
2006: 59
07
2007: 39
08
2008: 103
09
2009: 97
10
2010: 153
11
2011: 199
12
2012: 170
13
2013: 148
14
2014: 166
15
2015: 196
16
2016: 280
17
2017: 296
18
2018: 305
19
2019: 1,028
20
2020: 607
21
2021: 512
22
2022: 268
23
2023: 265
24
2024: 197
25
2025: 276
26
2026: 106

Reports in 2025 (276) held close to the prior two-year average of 231.

Related Entities for Holder, Head, Neurosurgical (Skull Clamp)

Top Manufacturers

INTEGRA LIFESCIENCES CORPORATION OH/USA 3,934

Event Locations

I 2,921 (50.1%)
2,344 (40.2%)
HOSPITAL 487 (8.4%)
NO INFORMATION 63 (1.1%)
INVALID DATA 3 (0.1%)
HOME 2 (0.0%)
OPERATING ROOM 2 (0.0%)
OTHER 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Holder, Head, Neurosurgical: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,826 here).

Extended Depth Of Focus Intraocular Lens 5,816 Catheter, Irrigation 5,798 Stent, Ureteral 5,858 Ultrasound Bronchoscope 5,860

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Holder, Head, Neurosurgical are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Holder, Head, Neurosurgical; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.