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Elevator, Surgical, Dental

Open-data reference.

FDA MAUDE adverse event data · 2005–2026

What the Data Shows About Elevator, Surgical, Dental

The FDA MAUDE database aggregates 634 adverse-event reports for Elevator, Surgical, Dental spanning the period from 2005 through 2026. Of these, 0 are classified as death reports, 99 as injury reports, and 531 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 6 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 16 distinct product-problem codes appear in the reports, with Fracture topping the list at 487 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 21 years of MAUDE data, with the peak single-year volume reaching 85 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.

634
Total Reports
0
Death Reports
99
Injury Reports
531
Malfunctions

Event Types

Malfunction 531 (83.8%)
Injury 99 (15.6%)
2 (0.3%)
Other 2 (0.3%)

Patient Outcomes

522 (81.7%)
Required Intervention 97 (15.2%)
Other 12 (1.9%)
R 4 (0.6%)
Hospitalization 3 (0.5%)
O 1 (0.2%)

Top Product Problems

Fracture 487
Break 29
Naturally Worn 21
Bent 9
Crack 8
Material Fragmentation 6
Material Integrity Problem 2
Corroded 1
Degraded 1
Detachment of Device or Device Component 1
Device Inoperable 1
Device Or Device Fragments Location Unknown 1
Insufficient Information 1
Material Separation 1
Material Twisted/Bent 1
Use of Device Problem 1

Yearly Trend

05
2005: 1
06
2006: 1
08
2008: 1
09
2009: 1
10
2010: 3
11
2011: 6
12
2012: 5
13
2013: 2
14
2014: 19
15
2015: 44
16
2016: 85
17
2017: 59
18
2018: 68
19
2019: 73
20
2020: 39
21
2021: 65
22
2022: 46
23
2023: 45
24
2024: 27
25
2025: 43
26
2026: 1

Related Entities for Elevator, Surgical, Dental

Event Locations

I 388 (61.2%)
240 (37.9%)
NO INFORMATION 2 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
HOSPITAL 1 (0.2%)
OTHER 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Compare BIOMET MICROFIXATION vs INTEGRA YORK, PA INC. →

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.