MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for MAGEC? SYSTEM RA002-4545SLR70 manufactured by Nuvasive Specialized Orthopedics, Incorporated.
[183371698]
No product has been returned for evaluation as it was returned to (b)(4). No root cause can be confirmed at this time.
Patient Sequence No: 1, Text Type: N, H10
[183371699]
Information was received that a revision procedure was performed. As per the reporter, the rods were removed due to the patient developing an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006179046-2020-00131 |
| MDR Report Key | 9829407 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIARA RAE |
| Manufacturer Street | 101 ENTERPRISE SUITE 100 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer G1 | NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED |
| Manufacturer Street | 101 ENTERPRISE SUITE 100 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGEC? SYSTEM |
| Generic Name | GROWING ROD SYSTEM- MAGNETIC ACTUATION |
| Product Code | PGN |
| Date Received | 2020-03-13 |
| Model Number | RA002-4545SLR70 |
| Lot Number | A151021-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED |
| Manufacturer Address | 101 ENTERPRISE SUITE 100 ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |