MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-25 for IRIX-A LUMBAR INTEGRATED FUSION SYSTEM T080-0100-4 manufactured by X-spine Systems, Inc..
[179294709]
The complainant reported that the upper articulating arm of a pituitary rongeur came off during a procedure. The piece was retrieved with no complications or delay in treatment. There were no reported patient complications associated with this event. The complainant reported that the sets have been in use for at least two years, and that this size pituitary rongeur is used the most during the surgeon's procedures. A visual assessment of the complaint instrument identified that the bottom cutting surface of the pituitary rongeur was worn. The articulating arm that is intended to have the superior cutting surface present was fractured. The three spot welds intended to secure the pivot pin of the instrument/distal handle interface were broken and the pivot pin was shifted out of placement and protruding on one side. A functionality assessment could not be performed due to the broken condition of the instrument. If repeated excessive compression force was applied to the handles of the instrument, it could contribute to an instrument malfunction at the area where stress risers are present. A dhr review was performed and there were no manufacturing anomalies identified. The device met all required specifications prior to initially being released to distributable inventory. This lot has been available for distribution since 2/03/2016.
Patient Sequence No: 1, Text Type: N, H10
[179294710]
The complainant reported that the upper articulating arm of a pituitary rongeur came off during a procedure. The piece was retrieved with no complications or delay in treatment. There were no reported patient complications associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2019-00045 |
| MDR Report Key | 9242297 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-10-25 |
| Date of Report | 2019-10-25 |
| Date of Event | 2019-10-10 |
| Date Mfgr Received | 2019-10-18 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2019-10-25 |
| 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 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-A LUMBAR INTEGRATED FUSION SYSTEM |
| Generic Name | INTERVERTEBRAL BODY FUSION DEVICE |
| Product Code | HTX |
| Date Received | 2019-10-25 |
| Returned To Mfg | 2019-10-24 |
| Model Number | T080-0100-4 |
| Lot Number | XS157369D |
| 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 | 2019-10-25 |