MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-15 for IRIX-C GUIDED ANGLE AWL T066-0061 manufactured by X-spine Systems, Inc..
[77702839]
The awl was found to be bent at the distal tip, it is not known if this was due to the patient's hard bone or the surgeon's failure to use the guided instrumentation that must be used with this system.
Patient Sequence No: 1, Text Type: N, H10
[77702840]
During a revision surgery to remove non x-spine cervical plate and replace it with irix-c implant on adjacent levels, there were complications with hard bone. The surgeon used several tools to try to start a pilot hole; the freehand awl was bent, the guided angled awl was broken, a 14mm drill was bent, a 14mm drill was broken, and one straight awl was bent. There were no patient injuries due to the broken and bent instruments. Surgeon was able to start a pilot hole with a self-drilling screw after several attempts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2017-00140 |
| MDR Report Key | 6645779 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-15 |
| 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 | 3 |
| Brand Name | IRIX-C GUIDED ANGLE AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2017-06-15 |
| Returned To Mfg | 2017-05-18 |
| Model Number | T066-0061 |
| Lot Number | 67629 |
| 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 | 2017-06-15 |