2026 data FDA MAUDE openFDA

Locator, Root Apex

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 MAUDE casebook

openFDA event book Locator, Root Apex LIGHT-BOOK · MAUDE

#585 of 1000 · 1,412 reports · 2008–2026

  • BOOK 1,412 reports
  • RANK #585 of 1000
  • DEATH 0 death-typed
  • INJ 9 injury-typed
  • MALF 1,403 malfunction
  • SPAN 2008–2026
  • PEAK 2019: 163
  • PHOTO External Mandibular F…

Nearest event-volume peer: External Mandibular Fixator And/Or Distractor (4 report gap)

Locator, Root Apex sits #585 of 1000 among tracked device types with 1,412 MAUDE reports spanning 2008–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Locator, Root Apex carries 99.4% MALFUNCTION-coded reports, 34.5pp 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 0.6% corpus 30.3% · below corpus mean (-29.7 pp)
  • MALF 99.4% corpus 64.8% · above corpus mean (+34.5 pp)

Lead product-problem code Incorrect Measurement is 93% of coded problems · Top event location I is 58% of location-tagged rows .

Locator, Root Apex in the event-volume neighbourhood

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

reports

What this shows Locator, Root Apex carries 1,412 MAUDE reports, ranked #585 of 1000.

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

Event Types

Malfunction 1,403 (99.4%)
Injury 9 (0.6%)

Patient Outcomes

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

1,395 (99.3%)
Disability 3 (0.2%)
Other 3 (0.2%)
Required Intervention 3 (0.2%)
Hospitalization 1 (0.1%)

Top Product Problems

Incorrect Measurement 1,362
Incorrect, Inadequate or Imprecise Result or Readings 36
Device Operates Differently Than Expected 14
Material Separation 9
Insufficient Device Problem Information 5
Mechanical Problem 5
Output Problem 4
Device Handling Problem 3
False Reading From Device Non-Compliance 3
Improper Device Output 3
Measurement System Incompatibility 3
Patient-Device Incompatibility 3
Unintended Electrical Shock 3
Adverse Event Without Identified Device or Use Problem 2
Detachment of Device or Device Component 2
Device Sensing Problem 2
Electrical /Electronic Property Problem 2
Inappropriate/Inadequate Shock/Stimulation 2
No Display/Image 2
Overheating of Device 2

Yearly Trend

08
2008: 1
09
2009: 15
10
2010: 22
11
2011: 140
12
2012: 59
13
2013: 2
15
2015: 59
16
2016: 128
17
2017: 133
18
2018: 154
19
2019: 163
20
2020: 139
21
2021: 107
22
2022: 63
23
2023: 56
24
2024: 81
25
2025: 52
26
2026: 38

Reports in 2025 (52) held close to the prior two-year average of 69.

Related Entities for Locator, Root Apex

Event Locations

I 821 (58.1%)
582 (41.2%)
NO INFORMATION 8 (0.6%)
OTHER 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Locator, Root Apex 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 (1,412 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 Locator, Root Apex 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 Locator, Root Apex; 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.