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2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Bone Growth, Non-Invasive

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 §890.5870 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Stimulator, Bone Growth, Non-Invasive LIGHT-BOOK · MAUDE

#582 of 1000 · 1,433 reports · 1995–2026

  • BOOK 1,433 reports
  • RANK #582 of 1000
  • DEATH 5 death-typed
  • INJ 1,381 injury-typed
  • MALF 34 malfunction
  • SPAN 1995–2026
  • PEAK 2021: 246
  • PHOTO Bariatric Bed

Nearest event-volume peer: Bariatric Bed (8 report gap)

Stimulator, Bone Growth, Non-Invasive sits #582 of 1000 among tracked device types with 1,433 MAUDE reports spanning 1995–2026. 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 →

Injury-coded reports run above the device-type norm

Stimulator, Bone Growth, Non-Invasive carries 96.4% INJURY-coded reports, 66.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 96.4% corpus 30.3% · above corpus mean (+66.1 pp)
  • MALF 2.4% corpus 64.8% · below corpus mean (-62.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer UNKNOWN accounts for 100% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Stimulator, Bone Growth, Non-Invasive in the event-volume neighbourhood

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

reports

What this shows Stimulator, Bone Growth, Non-Invasive carries 1,433 MAUDE reports, ranked #582 of 1000.

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

Event Types

Injury 1,381 (96.4%)
Malfunction 34 (2.4%)
7 (0.5%)
Other 6 (0.4%)
Death 5 (0.3%)

Patient Outcomes

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

Required Intervention 852 (56.6%)
Other 319 (21.2%)
185 (12.3%)
R 55 (3.7%)
Hospitalization 46 (3.1%)
O 20 (1.3%)
S 15 (1.0%)
Disability 4 (0.3%)
Death 3 (0.2%)
H 2 (0.1%)
L 2 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 674
Patient-Device Incompatibility 654
Insufficient Device Problem Information 470
Off-Label Use 41
Appropriate Device Problem Term/Code Not Available 19
Unknown (for use when the device problem is not known) 18
Biocompatibility 13
Overheating of Device 11
Device Operates Differently Than Expected 9
Patient Device Interaction Problem 9
Inappropriate/Inadequate Shock/Stimulation 6
Temperature Problem 5
Device-Device Incompatibility 4
Use of Device Problem 4
Device Issue 3
Device, removal of (non-implant) 3
No Apparent Adverse Event 3
Nonstandard Device 3
Therapeutic or Diagnostic Output Failure 3
Unintended Electrical Shock 3

Yearly Trend

95
1995: 3
97
1997: 2
98
1998: 4
99
1999: 4
00
2000: 1
01
2001: 5
02
2002: 3
03
2003: 2
04
2004: 3
05
2005: 2
07
2007: 8
08
2008: 7
09
2009: 2
10
2010: 3
11
2011: 8
12
2012: 5
13
2013: 13
14
2014: 3
15
2015: 31
16
2016: 48
17
2017: 55
18
2018: 36
19
2019: 54
20
2020: 142
21
2021: 246
22
2022: 158
23
2023: 148
24
2024: 173
25
2025: 164
26
2026: 100

Reports in 2025 (164) held close to the prior two-year average of 161.

Related Entities for Stimulator, Bone Growth, Non-Invasive

Top Manufacturers

UNKNOWN 7

Event Locations

1,072 (74.8%)
I 324 (22.6%)
NO INFORMATION 13 (0.9%)
HOME 11 (0.8%)
UNKNOWN 5 (0.3%)
AMBULATORY SURGICAL FACILITY 3 (0.2%)
OTHER 2 (0.1%)
HOSPITAL 1 (0.1%)
INVALID DATA 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Bone Growth, Non-Invasive: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,433 here).

Bariatric Bed 1,441 Prosthesis 1,423 Slide Stainer, Automated 1,446 Fluid Jet Removal System 1,449

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Stimulator, Bone Growth, Non-Invasive 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 Stimulator, Bone Growth, Non-Invasive; 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.