MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-07 for IRIX-C GUIDED ANGLE AWL T066-0205 manufactured by X-spine Systems, Inc..
[89940475]
Awl has not been received for evaluation. Answers to questions about the reported incident have not been received either.
Patient Sequence No: 1, Text Type: N, H10
[89940476]
The tip of the awl was broken during a case. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005031160-2017-00160 |
MDR Report Key | 6926112 |
Report Source | DISTRIBUTOR,FOREIGN |
Date Received | 2017-10-07 |
Date of Report | 2017-10-06 |
Date Mfgr Received | 2017-09-06 |
Date Added to Maude | 2017-10-07 |
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 | 2017-10-07 |
Model Number | T066-0205 |
Lot Number | EM12M005 |
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 | 2017-10-07 |