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2026 data FDA MAUDE openFDA FDA Class II

Dura Substitute

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 §882.5910 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Dura Substitute LIGHT-BOOK · MAUDE

#590 of 1000 · 1,397 reports · 1996–2026

  • BOOK 1,397 reports
  • RANK #590 of 1000
  • DEATH 36 death-typed
  • INJ 1,053 injury-typed
  • MALF 178 malfunction
  • SPAN 1996–2026
  • PEAK 2020: 114
  • PHOTO Dressing

Nearest event-volume peer: Dressing, Wound, Hydrophilic (0 report gap)

Dura Substitute sits #590 of 1000 among tracked device types with 1,397 MAUDE reports spanning 1996–2026. 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 →

Malfunction reports sit below the device-type norm

Dura Substitute carries 12.7% MALFUNCTION-coded reports, 52.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 75.4% corpus 30.3% · above corpus mean (+45.1 pp)
  • MALF 12.7% corpus 64.8% · below corpus mean (-52.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 36% of coded problems · Lead manufacturer MEDTRONIC NEUROSURGERY accounts for 84% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .

Dura Substitute in the event-volume neighbourhood

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

reports

What this shows Dura Substitute carries 1,397 MAUDE reports, ranked #590 of 1000.

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

Event Types

Injury 1,053 (75.4%)
Malfunction 178 (12.7%)
Other 69 (4.9%)
61 (4.4%)
Death 36 (2.6%)

Patient Outcomes

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

476 (28.2%)
Required Intervention 383 (22.7%)
Other 319 (18.9%)
R 188 (11.2%)
Hospitalization 172 (10.2%)
O 46 (2.7%)
Death 35 (2.1%)
H 25 (1.5%)
L 24 (1.4%)
Life Threatening 7 (0.4%)
S 6 (0.4%)
D 3 (0.2%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 446
Insufficient Device Problem Information 174
Explanted 76
Leak/Splash 74
Unknown (for use when the device problem is not known) 72
Appropriate Device Problem Term/Code Not Available 60
Fluid/Blood Leak 45
Device remains implanted 38
Nonstandard Device 30
Material Disintegration 29
Other (for use when an appropriate device code cannot be identified) 28
Replace 28
Device Operates Differently Than Expected 24
Product Quality Problem 22
Material Puncture/Hole 21
Degraded 18
Sterility 16
Performance 14
Contamination 13
Material Integrity Problem 13

Yearly Trend

96
1996: 8
97
1997: 20
98
1998: 7
99
1999: 10
00
2000: 20
01
2001: 19
02
2002: 16
03
2003: 15
04
2004: 22
05
2005: 43
06
2006: 42
07
2007: 55
08
2008: 43
09
2009: 46
10
2010: 36
11
2011: 31
12
2012: 38
13
2013: 72
14
2014: 18
15
2015: 62
16
2016: 58
17
2017: 57
18
2018: 94
19
2019: 63
20
2020: 114
21
2021: 76
22
2022: 59
23
2023: 109
24
2024: 55
25
2025: 63
26
2026: 26

Reports in 2025 (63) held close to the prior two-year average of 82.

Related Entities for Dura Substitute

Top Manufacturers

MEDTRONIC NEUROSURGERY 199
AESCULAP AG 38

Event Locations

774 (55.4%)
I 455 (32.6%)
HOSPITAL 138 (9.9%)
NO INFORMATION 15 (1.1%)
INVALID DATA 6 (0.4%)
OTHER 4 (0.3%)
HOME 3 (0.2%)
UNKNOWN 2 (0.1%)

Compare MEDTRONIC NEUROSURGERY vs AESCULAP AG →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dura Substitute: 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 (1,397 here).

Dressing, Wound, Hydrophilic 1,397 Lens, Intraocular, Accommodative 1,402 Sacroiliac Joint Fixation 1,406 Unit, Operative Dental 1,407

Similar death-typed counts

Nearest other device types by death-typed report count (36 here), distinct from the volume row.

Arthroscope 36 Compressor, Air, Portable 36 Heart-Valve, Allograft 36 Adhesive 35

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

Disclaimer: MAUDE figures for Dura Substitute 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 Dura Substitute; 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.