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 SPINAL BRACING AND DISTRACTION SYSTEM RA002-4545SL70 manufactured by Nuvasive Specialized Orthopedics, Inc..
[183373732]
No product has been returned for evaluation. Evaluation was performed by (b)(4). No lab culture results were provided to confirm the reported event. No root cause can be confirmed at this time. Device returned to (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183373733]
Information was received that a revision procedure was performed. As per the reporter, the rod was removed because the patient developed an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006179046-2020-00145 |
| MDR Report Key | 9831004 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2015-10-21 |
| 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 Phone | 6197314188 |
| Manufacturer G1 | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
| 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 SPINAL BRACING AND DISTRACTION SYSTEM |
| Generic Name | GROWING ROD SYSTEM-MAGNETIC ACTUATION |
| Product Code | PGN |
| Date Received | 2020-03-13 |
| Model Number | RA002-4545SL70 |
| Lot Number | A151021-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
| 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 |