2025 data FDA MAUDE openFDA FDA Class II

Growing Rod System- Magnetic Actuation

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 §888.3070 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Growing Rod System- Magnetic Actuation LIGHT-BOOK · MAUDE

#643 of 1000 · 1,094 reports · 2014–2025

  • BOOK 1,094 reports
  • RANK #643 of 1000
  • DEATH 0 death-typed
  • INJ 426 injury-typed
  • MALF 667 malfunction
  • SPAN 2014–2025
  • PEAK 2020: 339
  • PHOTO Laryngoscope

Nearest event-volume peer: Laryngoscope, Non-Rigid (5 report gap)

Growing Rod System- Magnetic Actuation sits #643 of 1000 among tracked device types with 1,094 MAUDE reports spanning 2014–2025. 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 →

Injury-coded reports run above the device-type norm

Growing Rod System- Magnetic Actuation carries 38.9% INJURY-coded reports, 8.6pp 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 38.9% corpus 30.3% · above corpus mean (+8.6 pp)
  • MALF 61.0% corpus 64.8% · below corpus mean (-3.9 pp)

Lead product-problem code Defective Device is 17% of coded problems · Top event location I is 62% of location-tagged rows .

Growing Rod System- Magnetic Actuation in the event-volume neighbourhood

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

reports

What this shows Growing Rod System- Magnetic Actuation carries 1,094 MAUDE reports, ranked #643 of 1000.

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

Event Types

Malfunction 667 (61.0%)
Injury 426 (38.9%)
1 (0.1%)

Patient Outcomes

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

535 (44.1%)
Hospitalization 266 (21.9%)
Required Intervention 233 (19.2%)
R 95 (7.8%)
Other 53 (4.4%)
O 22 (1.8%)
H 3 (0.2%)
Congenital Anomaly 2 (0.2%)
Disability 2 (0.2%)
S 1 (0.1%)

Top Product Problems

Defective Device 240
Break 171
Mechanical Jam 142
Mechanical Problem 133
Corroded 130
Failure to Advance 96
Migration or Expulsion of Device 59
Adverse Event Without Identified Device or Use Problem 55
Fracture 55
Migration 43
Physical Resistance/Sticking 39
Naturally Worn 35
Degraded 28
Scratched Material 28
Structural Problem 27
Defective Component 26
Device Operates Differently Than Expected 26
Detachment of Device or Device Component 25
Insufficient Device Problem Information 21
Appropriate Device Problem Term/Code Not Available 17

Yearly Trend

14
2014: 12
15
2015: 16
16
2016: 18
17
2017: 31
18
2018: 45
19
2019: 86
20
2020: 339
21
2021: 204
22
2022: 120
23
2023: 189
24
2024: 30
25
2025: 4

Reports fell to 30 in 2024, down from an average of 155 in the two years before.

Related Entities for Growing Rod System- Magnetic Actuation

Event Locations

I 676 (61.8%)
409 (37.4%)
NO INFORMATION 5 (0.5%)
HOSPITAL 4 (0.4%)

Nationwide devices with a comparable report-volume footprint

Growing Rod System- Magnetic Actuation 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 (1,094 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 Growing Rod System- Magnetic Actuation 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 Growing Rod System- Magnetic Actuation; 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.