MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-05 for XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM X073-6540 manufactured by X-spine Systems, Inc..
[182291763]
The company was notified that a revision was planned for a patient. No information was provided to suggest that the planned revision was due to the device contributing to serious injury as a result of failure, malfunction, improper or inadequate design, manufacture, labeling or user error. This report is being submitted precautionary measure as the company continues to obtain information from the reporter. Subsequent mdrs will be submitted, if necessary.
Patient Sequence No: 1, Text Type: N, H10
[182291764]
The company was notified that a revision was planned for a patient. No information was provided to suggest that the planned revision was due to the device contributing to serious injury as a result of failure, malfunction, improper or inadequate design, manufacture, labeling or user error. This report is being submitted precautionary measure as the company continues to obtain information from the reporter. Subsequent mdrs will be submitted, if necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2020-00006 |
| MDR Report Key | 9795830 |
| Report Source | FOREIGN |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-03-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY MING |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE, MT |
| Manufacturer Country | US |
| Manufacturer Phone | 3880480112 |
| Manufacturer G1 | X-SPINE SYSTEMS, INC. |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE, MT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | MNI |
| Date Received | 2020-03-05 |
| Model Number | X073-6540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | X-SPINE SYSTEMS, INC. |
| Manufacturer Address | 664 CRUISER LANE BELGRADE, MT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-05 |