MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-29 for * 4107-8 manufactured by Stryker Instruments.
[20141471]
During a cabg, coronay artery bypass graft, surgery, the surgeon was using a saw with a saw guard to open the chest. The saw guard broke into pieces. All parts were retrieved and there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 588525 |
| MDR Report Key | 588525 |
| Date Received | 2005-03-29 |
| Date of Report | 2005-03-21 |
| Date of Event | 2005-03-10 |
| Report Date | 2005-03-21 |
| Date Reported to FDA | 2005-03-29 |
| Date Added to Maude | 2005-04-08 |
| 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 | * |
| Generic Name | STERNUM BLADE GUARD |
| Product Code | LXZ |
| Date Received | 2005-03-29 |
| Model Number | 4107-8 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 578376 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-29 |