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2026 data FDA MAUDE openFDA FDA Class I

Elevator, Surgical, 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 §872.4565 (Dental panel).

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FDA MAUDE casebook

openFDA event book Elevator, Surgical, Dental LIGHT-BOOK · MAUDE

#806 of 1000 · 638 reports · 2005–2026

  • BOOK 638 reports
  • RANK #806 of 1000
  • DEATH 0 death-typed
  • INJ 99 injury-typed
  • MALF 535 malfunction
  • SPAN 2005–2026
  • PEAK 2016: 85
  • PHOTO Outpatient Cardiac Te…

Nearest event-volume peer: Outpatient Cardiac Telemetry (0 report gap)

Elevator, Surgical, Dental sits #806 of 1000 among tracked device types with 638 MAUDE reports spanning 2005–2026. 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

Elevator, Surgical, Dental carries 83.9% MALFUNCTION-coded reports, 19.0pp 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 15.5% corpus 30.3% · below corpus mean (-14.8 pp)
  • MALF 83.9% corpus 64.8% · above corpus mean (+19.0 pp)

Lead product-problem code Fracture is 74% of coded problems · Lead manufacturer BIOMET MICROFIXATION accounts for 98% of manufacturer-tagged reports · Top event location I is 61% of location-tagged rows .

Elevator, Surgical, Dental in the event-volume neighbourhood

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

reports

What this shows Elevator, Surgical, Dental carries 638 MAUDE reports, ranked #806 of 1000.

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

Event Types

Malfunction 535 (83.9%)
Injury 99 (15.5%)
2 (0.3%)
Other 2 (0.3%)

Patient Outcomes

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

525 (81.6%)
Required Intervention 97 (15.1%)
Other 13 (2.0%)
R 4 (0.6%)
Hospitalization 3 (0.5%)
O 1 (0.2%)

Top Product Problems

Fracture 497
Break 105
Naturally Worn 21
Bent 9
Crack 8
Material Fragmentation 7
Detachment Of Device Component 6
Material Integrity Problem 3
Off-Label Use 3
Component Falling 2
Device Or Device Fragments Location Unknown 2
Entrapment of Device 2
Tip breakage 2
Corroded 1
Defective Component 1
Degraded 1
Detachment of Device or Device Component 1
Device Inoperable 1
Device Operates Differently Than Expected 1
Device, or device fragments remain in patient 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: 5

Reports in 2025 (43) held close to the prior two-year average of 36.

Related Entities for Elevator, Surgical, Dental

Top Manufacturers

BIOMET MICROFIXATION 576
AESCULAP AG 6
UNKNOWN 2
AESCULAP AG 1

Event Locations

I 388 (60.8%)
244 (38.2%)
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 AESCULAP AG →

Nationwide devices with a comparable report-volume footprint

Elevator, Surgical, 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 (638 here).

Outpatient Cardiac Telemetry 638 Table 638 Instrument, Ligature Passing And Knot Tying 635 Polymer Patient Examination Glove 635

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 Elevator, Surgical, 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 Elevator, Surgical, 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.