2024 data FDA MAUDE openFDA FDA Class II

Unit, X-Ray, Extraoral With Timer

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 II (moderate risk, special controls required), regulated under 21 CFR §872.1800 (Dental panel).

FDA MAUDE casebook

openFDA event book Unit, X-Ray, Extraoral With Timer LIGHT-BOOK · MAUDE

#876 of 1000 · 521 reports · 1995–2024

  • BOOK 521 reports
  • RANK #876 of 1000
  • DEATH 0 death-typed
  • INJ 105 injury-typed
  • MALF 404 malfunction
  • SPAN 1995–2024
  • PEAK 2015: 110
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Traction, Non-Powered (2 report gap)

Unit, X-Ray, Extraoral With Timer sits #876 of 1000 among tracked device types with 521 MAUDE reports spanning 1995–2024. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Unit, X-Ray, Extraoral With Timer carries 77.5% MALFUNCTION-coded reports, 12.7pp 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 20.2% corpus 30.3% · below corpus mean (-10.1 pp)
  • MALF 77.5% corpus 64.8% · above corpus mean (+12.7 pp)

Lead product-problem code Component Falling is 19% of coded problems · Top event location is 57% of location-tagged rows .

Unit, X-Ray, Extraoral With Timer in the event-volume neighbourhood

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

reports

What this shows Unit, X-Ray, Extraoral With Timer carries 521 MAUDE reports, ranked #876 of 1000.

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

Event Types

Malfunction 404 (77.5%)
Injury 105 (20.2%)
9 (1.7%)
No answer provided 2 (0.4%)
Other 1 (0.2%)

Patient Outcomes

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

390 (73.0%)
Other 90 (16.9%)
Required Intervention 22 (4.1%)
Hospitalization 16 (3.0%)
O 11 (2.1%)
Life Threatening 3 (0.6%)
R 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Component Falling 119
Battery Problem 96
Nonstandard Device 52
Detachment Of Device Component 50
Break 37
Migration or Expulsion of Device 37
Self-Activation or Keying 35
Device Operates Differently Than Expected 28
Installation-Related Problem 20
Material Separation 20
Device Operational Issue 18
Device Dislodged or Dislocated 16
Noise, Audible 16
Thermal Decomposition of Device 13
Collapse 10
Crack 9
Device Slipped 9
Mechanical Problem 9
Melted 9
Fire 8

Yearly Trend

95
1995: 3
96
1996: 1
97
1997: 6
98
1998: 2
99
1999: 4
01
2001: 2
02
2002: 5
03
2003: 2
04
2004: 6
05
2005: 3
06
2006: 1
07
2007: 5
08
2008: 6
09
2009: 38
10
2010: 47
11
2011: 26
12
2012: 22
13
2013: 21
14
2014: 20
15
2015: 110
16
2016: 63
17
2017: 66
18
2018: 21
19
2019: 21
20
2020: 4
21
2021: 4
22
2022: 4
23
2023: 2
24
2024: 6

Reports fell to 2 in 2023, down from an average of 4 in the two years before.

Related Entities for Unit, X-Ray, Extraoral With Timer

Event Locations

296 (56.8%)
I 181 (34.7%)
NO INFORMATION 29 (5.6%)
OTHER 5 (1.0%)
HOSPITAL 3 (0.6%)
UNKNOWN 3 (0.6%)
OUTPATIENT TREATMENT FACILITY 2 (0.4%)
INVALID DATA 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Unit, X-Ray, Extraoral With Timer 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 (521 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 Unit, X-Ray, Extraoral With Timer 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 Unit, X-Ray, Extraoral With Timer; 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.