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 2020-02-20 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM RA002-4545SL manufactured by Nuvasive Specialized Orthopedics, Inc..
[182910709]
The device will not be returning to the manufacturer for evaluation. It will be sent to new castle engineering lab. Radiographs provided did not confirm the alleged event. No root cause can be confirmed at this time.
Patient Sequence No: 1, Text Type: N, H10
[182910710]
Information was received that a revision procedure was performed on (b)(6) 2020. As per reporter, the rods were not distracting well due to the position of the offset rod and the curve. When removed by the surgeon, reportedly, the rod had clear movement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006179046-2020-00110 |
| MDR Report Key | 9734700 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| 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 | ORTHOPEDIC INTERNAL FIXATION SYSTEMS, SPINAL |
| Product Code | PGN |
| Date Received | 2020-02-20 |
| Model Number | RA002-4545SL |
| Lot Number | A160407-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-20 |