MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-05-12 for HALL STERNUM SAW (PNEUMATIC) 00505900500 manufactured by Linvatec Corp.
[127667]
Per user information during telephone conversation--no report of device problem during use. It was reported that "the heart muscle had grown and adhered to the bone".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-1999-00019 |
| MDR Report Key | 223925 |
| Report Source | 05,06 |
| Date Received | 1999-05-12 |
| Date of Report | 1999-04-12 |
| Date of Event | 1998-12-31 |
| Date Mfgr Received | 1999-04-12 |
| Date Added to Maude | 1999-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL STERNUM SAW (PNEUMATIC) |
| Generic Name | STERNUM SAW (PNEUMATIC) |
| Product Code | KFK |
| Date Received | 1999-05-12 |
| Model Number | NA |
| Catalog Number | 00505900500 |
| Lot Number | NA |
| ID Number | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 210311 |
| Manufacturer | LINVATEC CORP |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 33773 US |
| Baseline Brand Name | HALL STERNUM SAW (PNEUMATIC) |
| Baseline Generic Name | STERNUM SAW PNEUMATIC |
| Baseline Model No | NA |
| Baseline Catalog No | 00505900500 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K801737 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-05-12 |