MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-26 for REPOSE AIRVANCE 68G1153A 76353200M manufactured by Medtronics.
[2218485]
Surgeon positioned device to hyoid area and was unable to fire device. Device locked and is non-functioning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2316021 |
| MDR Report Key | 2316021 |
| Date Received | 2011-10-26 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-10-03 |
| Report Date | 2011-10-26 |
| Date Reported to FDA | 2011-10-26 |
| Date Added to Maude | 2011-10-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPOSE AIRVANCE |
| Generic Name | BONE SCREW SYSTEM |
| Product Code | HWD |
| Date Received | 2011-10-26 |
| Model Number | 68G1153A |
| Catalog Number | 76353200M |
| Lot Number | 0205377206 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONICS |
| Manufacturer Address | 6743 SOUTHPOINT DR. N. JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-26 |