MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-12 for IRIX-C CERVICAL INTEGRATED FUSION SYSTEM T066-0205 NA manufactured by X-spine Systems, Inc..
[113878625]
The complainant reported to the company that a guided angled awl tip broke inside a cage during surgery. A dhr review was performed and there were no manufacturing anomalies identified. The device met all required specifications prior to being released for distribution. The damage to the distal tip of the awl could be replicated if lateral force was applied while seated in an implant, or from failure to use the guided inserter.
Patient Sequence No: 1, Text Type: N, H10
[113878626]
The complainant reported to the company that a guided angled awl tip broke inside a cage during surgery. There were no known patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2018-00021 |
| MDR Report Key | 7681901 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2014-07-02 |
| Date Added to Maude | 2018-07-12 |
| 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 | 3 |
| Brand Name | IRIX-C CERVICAL INTEGRATED FUSION SYSTEM |
| Generic Name | INTERVERTEBRAL BODY FUSION DEVICE |
| Product Code | HWJ |
| Date Received | 2018-07-12 |
| Returned To Mfg | 2018-06-22 |
| Model Number | T066-0205 |
| Catalog Number | NA |
| Lot Number | EM14F003 |
| 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 | 2018-07-12 |