MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-02-13 for IRIX-C GUIDED ANGLE AWL T066-0205 manufactured by X-spine Systems, Inc..
[67321204]
The distal tip fragment of the awl was not returned for evaluation with the awl.
Patient Sequence No: 1, Text Type: N, H10
[67321205]
Was returned due to broken with no communication from representative, found upon returning inspection broken at distal tip. Representative responded on (b)(6) 2017, the awl was broken during surgery, no problems from it. No patient injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2017-00114 |
| MDR Report Key | 6327186 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-02-13 |
| 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 | 2017-02-13 |
| Returned To Mfg | 2016-12-16 |
| Model Number | T066-0205 |
| Lot Number | EM13M002 |
| 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 | 2017-02-13 |