MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-01-11 for IRIX-C GUIDED ANGLE AWL T066-0205 manufactured by X-spine Systems, Inc..
[64578059]
Awl was disposed of by hospital, not returned. Device disposed of.
Patient Sequence No: 1, Text Type: N, H10
[64578060]
The surgeon was using the guided angled awl on the c5 level, as he was hammering the pilot hole into the vertebral body he could see under fluoroscopy that the awl tip had sheared off. The awl shaft was removed from the surgical site and tip remained in c5 vertebral body. A pair of needle drivers were used to remove the awl tip from surgical site with no harm done to the patient. The awl tip and shaft were disposed of due to sharp edges and patient health history.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2017-00109 |
| MDR Report Key | 6244245 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2017-01-11 |
| 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 | 2017-01-11 |
| Model Number | T066-0205 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2017-01-11 |