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 2020-02-24 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM RA002-4545SL manufactured by Nuvasive Specialized Orthopedics, Inc..
[182910869]
No product has been returned for evaluation. Radiographs provided confirmed the alleged event. No root cause can be confirmed at this time.
Patient Sequence No: 1, Text Type: N, H10
[182910870]
Information was received that a revision procedure was performed on (b)(6) 2020. As per the reporter, x-rays revealed a pin break. Reportedly, the patient had been struck across the back with a wooden pole. During the removal, bone had fused around the rod and the surgeon had to use a small mallet to encourage the rod to move and loosen. Once removed, it was noted that there was positioning /movement in the rod.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006179046-2020-00114 |
| MDR Report Key | 9747852 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2013-10-04 |
| Date Added to Maude | 2020-02-24 |
| 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 | 2020-02-24 |
| Model Number | RA002-4545SL |
| Lot Number | A131004-02 |
| 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 | 2020-02-24 |