PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Needle, Dental

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.4730 (Dental panel).

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FDA MAUDE casebook

openFDA event book Needle, Dental LIGHT-BOOK · MAUDE

#783 of 1000 · 682 reports · 1995–2026

  • BOOK 682 reports
  • RANK #783 of 1000
  • DEATH 0 death-typed
  • INJ 360 injury-typed
  • MALF 292 malfunction
  • SPAN 1995–2026
  • PEAK 2009: 103
  • PHOTO Bit, Surgical

Nearest event-volume peer: Bit, Surgical (1 report gap)

Needle, Dental sits #783 of 1000 among tracked device types with 682 MAUDE reports spanning 1995–2026. 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 run above the device-type norm

Needle, Dental carries 52.8% INJURY-coded reports, 22.5pp 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 52.8% corpus 30.3% · above corpus mean (+22.5 pp)
  • MALF 42.8% corpus 64.8% · below corpus mean (-22.0 pp)

Lead product-problem code Break is 32% of coded problems · Lead manufacturer COVIDIEN accounts for 100% of manufacturer-tagged reports · Top event location OTHER is 36% of location-tagged rows .

Needle, Dental in the event-volume neighbourhood

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

reports

What this shows Needle, Dental carries 682 MAUDE reports, ranked #783 of 1000.

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

Event Types

Injury 360 (52.8%)
Malfunction 292 (42.8%)
Other 20 (2.9%)
10 (1.5%)

Patient Outcomes

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

263 (35.3%)
Required Intervention 223 (29.9%)
Other 147 (19.7%)
R 50 (6.7%)
Hospitalization 39 (5.2%)
O 8 (1.1%)
Disability 6 (0.8%)
S 5 (0.7%)
H 2 (0.3%)
Congenital Anomaly 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Break 242
Material Separation 79
Detachment Of Device Component 71
Material Fragmentation 55
Device Slipped 53
Detachment of Device or Device Component 42
Needle, separation 35
Device, or device fragments remain in patient 29
Difficult to Remove 28
Component(s), broken 26
Material Puncture/Hole 20
Entrapment of Device 16
Device, removal of (non-implant) 13
Tip breakage 11
Fitting Problem 10
Use of Device Problem 10
Bent 7
Loose or Intermittent Connection 6
Off-Label Use 6
Product Quality Problem 6

Yearly Trend

95
1995: 4
96
1996: 9
97
1997: 13
98
1998: 10
99
1999: 9
00
2000: 11
01
2001: 7
02
2002: 9
03
2003: 21
04
2004: 8
05
2005: 23
06
2006: 27
07
2007: 14
08
2008: 23
09
2009: 103
10
2010: 19
11
2011: 11
12
2012: 17
13
2013: 18
14
2014: 10
15
2015: 10
16
2016: 37
17
2017: 25
18
2018: 38
19
2019: 31
20
2020: 16
21
2021: 41
22
2022: 35
23
2023: 34
24
2024: 27
25
2025: 11
26
2026: 11

Reports fell to 11 in 2025, down from an average of 31 in the two years before.

Related Entities for Needle, Dental

Top Manufacturers

COVIDIEN 150

Event Locations

OTHER 243 (35.6%)
239 (35.0%)
I 141 (20.7%)
OUTPATIENT TREATMENT FACILITY 37 (5.4%)
UNKNOWN 7 (1.0%)
HOSPITAL 6 (0.9%)
INVALID DATA 6 (0.9%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.3%)
NURSING HOME 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Needle, Dental 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 (682 here).

Bit, Surgical 683 Stimulator, Muscle, Powered 678 Tube, Drainage, Suprapubic 677 Forceps, General & Plastic Surgery 673

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Needle, Dental 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 Needle, Dental; 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.