PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Instruments, Dental Hand

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).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Instruments, Dental Hand LIGHT-BOOK · MAUDE

#798 of 1000 · 656 reports · 1994–2026

  • BOOK 656 reports
  • RANK #798 of 1000
  • DEATH 0 death-typed
  • INJ 42 injury-typed
  • MALF 609 malfunction
  • SPAN 1994–2026
  • PEAK 2026: 151
  • PHOTO Guide

Nearest event-volume peer: Guide, Wire, Catheter, Neurovasculature (1 report gap)

Instruments, Dental Hand sits #798 of 1000 among tracked device types with 656 MAUDE reports spanning 1994–2026. 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

Instruments, Dental Hand carries 92.8% MALFUNCTION-coded reports, 28.0pp 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 6.4% corpus 30.3% · below corpus mean (-23.9 pp)
  • MALF 92.8% corpus 64.8% · above corpus mean (+28.0 pp)

Lead product-problem code Break is 86% of coded problems · Lead manufacturer ADIN DENTAL IMPLANT SYSTEMS LTD accounts for 63% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .

Instruments, Dental Hand in the event-volume neighbourhood

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

reports

What this shows Instruments, Dental Hand carries 656 MAUDE reports, ranked #798 of 1000.

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

Event Types

Malfunction 609 (92.8%)
Injury 42 (6.4%)
Other 3 (0.5%)
2 (0.3%)

Patient Outcomes

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

597 (91.0%)
Required Intervention 30 (4.6%)
Other 14 (2.1%)
R 9 (1.4%)
Hospitalization 5 (0.8%)
O 1 (0.2%)

Top Product Problems

Break 581
Replace 11
Separation Failure 10
Device Operates Differently Than Expected 8
Material Deformation 7
Material Integrity Problem 7
Bent 5
Crack 5
Device Issue 5
Flaked 5
Peeled/Delaminated 5
Detachment Of Device Component 4
Reaction 4
Adverse Event Without Identified Device or Use Problem 3
Design/structure problem 3
Fracture 3
Insufficient Device Problem Information 3
Material Separation 3
Other (for use when an appropriate device code cannot be identified) 3
Component Incompatible 2

Yearly Trend

94
1994: 1
95
1995: 4
97
1997: 1
02
2002: 15
03
2003: 1
06
2006: 2
08
2008: 1
09
2009: 4
10
2010: 1
11
2011: 1
13
2013: 79
14
2014: 76
15
2015: 51
16
2016: 30
17
2017: 17
18
2018: 9
19
2019: 12
20
2020: 15
21
2021: 21
22
2022: 26
23
2023: 38
24
2024: 69
25
2025: 31
26
2026: 151

Reports fell to 31 in 2025, down from an average of 54 in the two years before.

Related Entities for Instruments, Dental Hand

Top Manufacturers

ADIN DENTAL IMPLANT SYSTEMS LTD 17
AESCULAP AG 10

Event Locations

505 (77.0%)
I 114 (17.4%)
UNKNOWN 16 (2.4%)
HOSPITAL 7 (1.1%)
NO INFORMATION 7 (1.1%)
OUTPATIENT TREATMENT FACILITY 5 (0.8%)
INVALID DATA 1 (0.2%)
OTHER 1 (0.2%)

Compare ADIN DENTAL IMPLANT SYSTEMS LTD vs AESCULAP AG →

Nationwide devices with a comparable report-volume footprint

Instruments, Dental Hand 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 (656 here).

Guide, Wire, Catheter, Neurovasculature 657 Instrument For Treatment Of Hyperhidrosis 655 Cannula, Catheter 654 Full Field Digital 659

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 Instruments, Dental Hand 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 Instruments, Dental Hand; 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.