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Handpiece, Contra- And Right-Angle Attachment, Dental

Open-data reference.

FDA MAUDE adverse event data · 1994–2026

What the Data Shows About Handpiece, Contra- And Right-Angle Attachment, Dental

The FDA MAUDE database aggregates 2,523 adverse-event reports for Handpiece, Contra- And Right-Angle Attachment, Dental spanning the period from 1994 through 2026. Of these, 0 are classified as death reports, 721 as injury reports, and 1,791 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 4 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Overheating of Device topping the list at 1,257 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 24 years of MAUDE data, with the peak single-year volume reaching 316 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 7 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

2,523
Total Reports
0
Death Reports
721
Injury Reports
1,791
Malfunctions

Event Types

Malfunction 1,791 (71.0%)
Injury 721 (28.6%)
9 (0.4%)
Other 2 (0.1%)

Patient Outcomes

1,694 (66.7%)
Other 793 (31.2%)
Required Intervention 22 (0.9%)
R 8 (0.3%)
Hospitalization 7 (0.3%)
O 6 (0.2%)
Disability 3 (0.1%)
L 2 (0.1%)
S 2 (0.1%)
Congenital Anomaly 2 (0.1%)
H 1 (0.0%)

Top Product Problems

Overheating of Device 1,257
Detachment of Device or Device Component 589
Temperature Problem 204
Mechanical Problem 176
Detachment Of Device Component 94
Dent in Material 80
Output Problem 45
Therapeutic or Diagnostic Output Failure 43
Physical Resistance/Sticking 38
Defective Device 35
Incorrect Measurement 32
Loose or Intermittent Connection 30
Device Handling Problem 24
Failure To Service 22
Break 20
Improper or Incorrect Procedure or Method 14
Use of Device Problem 13
Noise, Audible 12
Failure to Align 11
Physical Property Issue 11

Yearly Trend

94
1994: 1
95
1995: 1
03
2003: 4
04
2004: 11
07
2007: 2
08
2008: 14
09
2009: 45
10
2010: 74
11
2011: 2
12
2012: 3
13
2013: 2
14
2014: 38
15
2015: 166
16
2016: 299
17
2017: 316
18
2018: 230
19
2019: 219
20
2020: 191
21
2021: 294
22
2022: 279
23
2023: 115
24
2024: 81
25
2025: 83
26
2026: 53

Related Entities for Handpiece, Contra- And Right-Angle Attachment, Dental

Event Locations

I 1,403 (55.6%)
685 (27.2%)
OTHER 255 (10.1%)
OUTPATIENT TREATMENT FACILITY 163 (6.5%)
NO INFORMATION 11 (0.4%)
HOSPITAL 4 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)

Compare NAKANISHI INC. vs DENTSPLY PROFESSIONAL →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.