MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-11-03 for IRIX-C GUIDED ANGLE AWL T066-0205 manufactured by X-spine Systems, Inc..
[91250757]
Awl has not been received for evaluation, however part number and lot number information was received.
Patient Sequence No: 1, Text Type: N, H10
[91250758]
The tip of the guided angle awl broke during surgery, it was already a little bent. There was no injury caused to the patient. The straight awl was then used to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2017-00161 |
| MDR Report Key | 7001813 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-11-03 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2017-10-06 |
| Device Manufacturer Date | 2014-06-25 |
| Date Added to Maude | 2017-11-03 |
| 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 | CHARLENE BRUMBAUGH |
| 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 | 2017-11-03 |
| Model Number | T066-0205 |
| Lot Number | EM14F003 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-03 |