MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-18 for IRIX-A LUMBAR INTEGRATED FUSION SYSTEM C080-0076 manufactured by X-spine Systems, Inc..
[60422564]
The specialty awl was returned but the extent of damage allowed only a visual evaluation to be performed.
Patient Sequence No: 1, Text Type: N, H10
[60422585]
A specialty awl was broken during surgery. There was no patient death reported, and no patient injury reported. The complainant reported that there was an initial anterior lumbar fusion surgery performed and a revision posterior lumbar fusion performed. The complainant did not report a date for when either surgery was performed. The complainant also did not specify if the specialty awl was broken during the initial procedure or the revision procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2016-00087 |
| MDR Report Key | 6115092 |
| Date Received | 2016-11-18 |
| Date of Report | 2016-11-18 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-11-18 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KRISS ANDERSON |
| Manufacturer Street | 452 ALEXANDERSVILLE ROAD |
| Manufacturer City | MIAMISBURG OH 45342 |
| Manufacturer Country | US |
| Manufacturer Postal | 45342 |
| Manufacturer Phone | 9378478400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2016-11-18 |
| Returned To Mfg | 2016-11-02 |
| Model Number | C080-0076 |
| Lot Number | SPE1628 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | X-SPINE SYSTEMS, INC. |
| Manufacturer Address | 452 ALEXANDERSVILLE ROAD MIAMISBURG OH 45342 US 45342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-18 |