MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for AXLE INTERSPINOUS FUSION SYSTEM X060-0318 NA manufactured by X-spine Systems, Inc..
[119498542]
The complainant reported that when the inserter and implant was being manipulated for placement, one of the handles of the inserter broke from the body of the instrument. The implant had already been placed through the opening prepared in the interspinous space when the malfunction occurred. No further placement or manipulation was required. There were no known patient complications. A visual inspection of the device confirmed the complainant's description of the damage. A dhr review was performed and the device met all required specifications prior to being released to distribution. The inserter malfunction could be replicated if excess force was applied to the handles of the inserter. The inserter ratchet is intended to hold the inserter in a fixed position with the implant loaded. If the handles are compressed further than the implant and ratchet allow, the handle of the inserter may break.
Patient Sequence No: 1, Text Type: N, H10
[119498543]
The complainant reported that when the inserter and implant was being manipulated for placement, one of the handles of the inserter broke from the body of the instrument. The implant had already been placed through the opening prepared in the interspinous space when the malfunction occurred. No further placement or manipulation was required. There were no known patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2018-00025 |
| MDR Report Key | 7843688 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-04 |
| Date Mfgr Received | 2018-08-10 |
| Device Manufacturer Date | 2014-10-06 |
| Date Added to Maude | 2018-09-04 |
| 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 | INTERSPINOUS PROCESS FIXATION SYSTEM |
| Product Code | PEK |
| Date Received | 2018-09-04 |
| Returned To Mfg | 2018-08-21 |
| Model Number | X060-0318 |
| Catalog Number | NA |
| Lot Number | I8365-0000R |
| 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 | 2018-09-04 |