2026 data FDA MAUDE openFDA FDA Class II

Neurosurgical Paddie

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 §882.4700 (Neurology panel).

FDA MAUDE casebook

openFDA event book Neurosurgical Paddie LIGHT-BOOK · MAUDE

#829 of 1000 · 600 reports · 1992–2026

  • BOOK 600 reports
  • RANK #829 of 1000
  • DEATH 0 death-typed
  • INJ 189 injury-typed
  • MALF 406 malfunction
  • SPAN 1992–2026
  • PEAK 2018: 58
  • PHOTO Device

Nearest event-volume peer: Device, Anastomotic, Microvascular (1 report gap)

Neurosurgical Paddie sits #829 of 1000 among tracked device types with 600 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 →

Malfunction reports run above the device-type norm

Neurosurgical Paddie carries 67.7% MALFUNCTION-coded reports, 2.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 31.5% corpus 30.3% · above corpus mean (+1.2 pp)
  • MALF 67.7% corpus 64.8% · above corpus mean (+2.8 pp)

Lead product-problem code Component Missing is 17% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 100% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Neurosurgical Paddie in the event-volume neighbourhood

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

reports

What this shows Neurosurgical Paddie carries 600 MAUDE reports, ranked #829 of 1000.

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

Event Types

Malfunction 406 (67.7%)
Injury 189 (31.5%)
3 (0.5%)
Other 2 (0.3%)

Patient Outcomes

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

386 (64.7%)
Required Intervention 155 (26.0%)
Other 45 (7.5%)
Hospitalization 5 (0.8%)
R 3 (0.5%)
O 1 (0.2%)
Disability 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Component Missing 91
Other (for use when an appropriate device code cannot be identified) 72
Contamination 46
Appropriate Device Problem Term/Code Not Available 42
Device Misassembled During Manufacturing /Shipping 33
Incorrect Device Or Component Shipped 30
Detachment of Device or Device Component 25
Device Contamination with Chemical or Other Material 24
Material Separation 24
Material Integrity Problem 23
Detachment Of Device Component 21
Material Frayed 17
Contamination /Decontamination Problem 15
Break 12
Manufacturing, Packaging or Shipping Problem 11
Device Contaminated During Manufacture or Shipping 10
Device, or device fragments remain in patient 8
Insufficient Device Problem Information 8
Material Discolored 8
Adverse Event Without Identified Device or Use Problem 7

Yearly Trend

92
1992: 1
97
1997: 2
98
1998: 3
99
1999: 8
00
2000: 2
01
2001: 1
02
2002: 3
03
2003: 4
04
2004: 3
05
2005: 2
06
2006: 1
07
2007: 12
08
2008: 20
09
2009: 14
10
2010: 25
11
2011: 17
12
2012: 13
13
2013: 19
14
2014: 43
15
2015: 38
16
2016: 40
17
2017: 35
18
2018: 58
19
2019: 57
20
2020: 31
21
2021: 44
22
2022: 28
23
2023: 29
24
2024: 27
25
2025: 5
26
2026: 15

Reports fell to 5 in 2025, down from an average of 28 in the two years before.

Related Entities for Neurosurgical Paddie

Top Manufacturers

Event Locations

291 (48.5%)
I 270 (45.0%)
HOSPITAL 30 (5.0%)
NO INFORMATION 9 (1.5%)

Nationwide devices with a comparable report-volume footprint

Neurosurgical Paddie carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (600 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Neurosurgical Paddie 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 Neurosurgical Paddie; 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.