MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-08-25 for TRIDENT RESECTION ABLATOR, 4.2MM ES-9247A manufactured by Linvatec Corporation.
[18147861]
During a shoulder acromial decompression procedure the tip of the device broke off. The tip was retrieved within a couple of minutes. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2005-00160 |
| MDR Report Key | 640844 |
| Report Source | 07 |
| Date Received | 2005-08-25 |
| Date of Report | 2005-07-27 |
| Date Mfgr Received | 2005-07-27 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-10-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | LINVATEC CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIDENT RESECTION ABLATOR, 4.2MM |
| Generic Name | RESECTION ABLATOR |
| Product Code | HXR |
| Date Received | 2005-08-25 |
| Model Number | NA |
| Catalog Number | ES-9247A |
| Lot Number | BBB89764 |
| ID Number | NA |
| Device Expiration Date | 2010-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 630353 |
| Manufacturer | LINVATEC CORPORATION |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | TRIDENT RESECTION ABLATOR, 4.2MM |
| Baseline Generic Name | RESECTION ABLATOR |
| Baseline Model No | NA |
| Baseline Catalog No | ES-9247A |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-25 |