2026 data FDA MAUDE openFDA FDA Class I

Syringe, Periodontic, Endodontic, Irrigating

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 §872.4565 (Dental panel).

FDA MAUDE casebook

openFDA event book Syringe, Periodontic, Endodontic, Irrigating LIGHT-BOOK · MAUDE

#945 of 1000 · 432 reports · 2002–2026

  • BOOK 432 reports
  • RANK #945 of 1000
  • DEATH 0 death-typed
  • INJ 21 injury-typed
  • MALF 411 malfunction
  • SPAN 2002–2026
  • PEAK 2019: 146
  • PHOTO Platelet And Plasma S…

Nearest event-volume peer: Platelet And Plasma Separator For Bone Graft Handling (0 report gap)

Syringe, Periodontic, Endodontic, Irrigating sits #945 of 1000 among tracked device types with 432 MAUDE reports spanning 2002–2026. 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

Syringe, Periodontic, Endodontic, Irrigating carries 95.1% MALFUNCTION-coded reports, 30.3pp 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 4.9% corpus 30.3% · below corpus mean (-25.4 pp)
  • MALF 95.1% corpus 64.8% · above corpus mean (+30.3 pp)

Lead product-problem code Break is 94% of coded problems · Lead manufacturer COVIDIEN accounts for 100% of manufacturer-tagged reports · Top event location I is 67% of location-tagged rows .

Syringe, Periodontic, Endodontic, Irrigating in the event-volume neighbourhood

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

reports

What this shows Syringe, Periodontic, Endodontic, Irrigating carries 432 MAUDE reports, ranked #945 of 1000.

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

Event Types

Malfunction 411 (95.1%)
Injury 21 (4.9%)

Patient Outcomes

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

420 (97.2%)
Other 9 (2.1%)
Required Intervention 3 (0.7%)

Top Product Problems

Break 414
Insufficient Device Problem Information 6
Detachment Of Device Component 4
Inadequacy of Device Shape and/or Size 3
Adverse Event Without Identified Device or Use Problem 2
Entrapment of Device 2
Peeled/Delaminated 2
Component Falling 1
Crack 1
Defective Component 1
Device Operates Differently Than Expected 1
Inaccurate Synchronization 1
Loose 1
Material Fragmentation 1
Overfill 1
Use of Device Problem 1

Yearly Trend

02
2002: 1
14
2014: 2
15
2015: 3
16
2016: 8
17
2017: 35
18
2018: 19
19
2019: 146
20
2020: 35
21
2021: 76
22
2022: 11
23
2023: 19
24
2024: 22
25
2025: 37
26
2026: 18

Reports rose to 37 in 2025, up from an average of 21 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Syringe, Periodontic, Endodontic, Irrigating

Top Manufacturers

Event Locations

I 289 (66.9%)
142 (32.9%)
NO INFORMATION 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Syringe, Periodontic, Endodontic, Irrigating 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 (432 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 Syringe, Periodontic, Endodontic, Irrigating 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 Syringe, Periodontic, Endodontic, Irrigating; 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.