MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for AXLE INTERSPINOUS FUSION SYSTEM X060-1520 NA manufactured by X-spine Systems, Inc..
[125290772]
The complainant reported that an axle all in one inserter broke during insertion of an implant. A second inserter was available, and the procedure was completed. There were no known patient complications. Visual assessment of the instrument identified that a subassembly part was sheared off which would prevent the inserter from functioning as intended. The fracture appeared to start on the inside corner of the tip where there is a sharp corner and potential stress riser. A dhr review was performed, and there were no manufacturing anomalies identified. The device met all required specifications prior to being released to distributable inventory.
Patient Sequence No: 1, Text Type: N, H10
[125290773]
The complainant reported that an axle all in one inserter broke during insertion of an implant. A second inserter was available, and the procedure was completed. There were no known patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2018-00031 |
| MDR Report Key | 8010522 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-26 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2018-10-26 |
| 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 | MR. CASEY MING |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer Phone | 4063880480 |
| Manufacturer G1 | X-SPINE SYSTEMS, INC. |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXLE INTERSPINOUS FUSION SYSTEM |
| Generic Name | PLIERS ALL-IN-ONE INSERTER/COMPRESSOR, ASSEMBLY |
| Product Code | HTC |
| Date Received | 2018-10-26 |
| Returned To Mfg | 2018-10-09 |
| Model Number | X060-1520 |
| Catalog Number | NA |
| Lot Number | 584601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | X-SPINE SYSTEMS, INC. |
| Manufacturer Address | 664 CRUISER LANE BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-26 |