MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-19 for SILEX SACROILIAC JOINT FUSION SYSTEM manufactured by X-spine Systems, Inc..
[184279757]
On (b)(6) 2020 system removal tools were requested to be distributed for a scheduled revision procedure in (b)(6) planned for (b)(6) 2020. Attempts to gather relevant incident information were made, however the reason for the revision procedure and relevant product information (i. E. Part number, lot number, etc. ) were unable to be provided. On (b)(6) 2020 the company received communication that all elective surgeries have been cancelled in canada until further notice. There was no information provided to suggest that the planned revision was due to the device contributing to a serious injury as a result of failure, malfunction, improper or inadequate design, manufacture, labeling or user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2020-00008 |
| MDR Report Key | 9853285 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-19 |
| 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 | SILEX SACROILIAC JOINT FUSION SYSTEM |
| Generic Name | SACROILIAC JOINT FIXATION/SACROILIAC JOINT FUSION |
| Product Code | OUR |
| Date Received | 2020-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-19 |