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Device brand name · Growing rod system - magnetic actuation
Magec Spinal Bracing And Distraction System: medical device reports filed with FDA
832 reports name it, 2014–2025. Manufacturer given most often on reports: Nuvasive Specialized Orthopedics. Product code PGN.
- 832
- device reports naming the brand
- 0% of all MAUDE reports · about 68 a year
- 0
- reports, 12 months to August 2026
- 4 in the 12 months before
- 56.3%
- classified as malfunction
- 60.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
832 medical device reports received by FDA name the brand "Magec Spinal Bracing And Distraction System" (growing rod system - magnetic actuation); the manufacturer given most often on reports is Nuvasive Specialized Orthopedics; received from April 2014 to May 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 4 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (56.3%) and injury (43.6%); across all growing rod system- magnetic actuation reports (product code PGN) death is recorded in 0% and malfunction in 60.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are defective device (24.9%), mechanical problem (15.9%) and break (12.3%). The patient problems coded most often are failure of implant, appropriate clinical signs, symptoms and conditions term/code not available and metal related pathology. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,095 reports carrying product code PGN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Defective devicethe device was defective | 207 | 24.9% | 21.9% |
| Mechanical problema mechanical problem | 132 | 15.9% | 12.1% |
| Breakthe device broke | 102 | 12.3% | 15.6% |
| Migration or expulsion of device | 52 | 6.3% | 5.4% |
| Fracturea broken bone | 45 | 5.4% | 5.1% |
| Migrationthe device moved from where it was placed | 40 | 4.8% | 3.8% |
| Mechanical jam | 37 | 4.4% | 13% |
| Corrodedthe device corroded | 36 | 4.3% | 11.9% |
| Naturally worn | 33 | 4% | 3.1% |
| Scratched material | 28 | 3.4% | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 24 | 2.9% | 2.4% |
| Defective component | 23 | 2.8% | 2.4% |
| Insufficient device problem information | 21 | 2.5% | 1.9% |
| Failure to advance | 18 | 2.2% | 8.7% |
| Degraded | 17 | 2% | 2.5% |
| Unstable | 16 | 1.9% | 1.4% |
| Material separation | 14 | 1.7% | 1.4% |
| Detachment of device or device componentpart of the device came off | 8 | 1% | 2.3% |
| Retraction problem | 8 | 1% | 0.7% |
| Physical resistance/sticking | 7 | 0.8% | 3.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Failure of implant | 530 | 63.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 23 | 2.8% |
| Metal related pathology | 16 | 1.9% |
| Painpain, site not specified | 12 | 1.4% |
| Skin discoloration | 7 | 0.8% |
| Fever | 5 | 0.6% |
| Inflammationinflammation | 5 | 0.6% |
| Wound dehiscencea wound reopened | 5 | 0.6% |
| Purulent discharge | 4 | 0.5% |
| Bacterial infectiona bacterial infection | 2 | 0.2% |
| Burning sensationa burning feeling | 2 | 0.2% |
| Decreased appetitereduced appetite | 2 | 0.2% |
| Deformity/ disfigurement | 2 | 0.2% |
| Drug resistant bacterial infection | 2 | 0.2% |
| Extraskeletal ossification | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Magec Spinal Bracing And Distraction System | Product code PGN | All MAUDE reports |
|---|---|---|---|
| Reports | 832 | 1,095 | 26,136,888 |
| Share of that pool | — | 76% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 43.6% | 39% | 36.2% |
| Classified as malfunction | 56.3% | 60.8% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PGN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Precice Intramedullary Limb Lengthening Rod | 177 | 0 | 0% |
| Precice Stryde System | 226 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Magec Spinal Bracing And Distraction System reports
How many FDA reports name Magec Spinal Bracing And Distraction System?
832 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (56.3%) and injury (43.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
defective device (24.9%), mechanical problem (15.9%), break (12.3%), migration or expulsion of device (6.3%) and fracture (5.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Magec Spinal Bracing And Distraction System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.