MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-09 for INNOVASIVE COR INNOVASIVE COR CUTTER 4MM 3513 manufactured by Innovasive Devices, Inc..
[90376]
Cor cutting device was used to harvest bone & cartilage from left knee to be transplanted into osteochondral defect. When harvested core was placed in defect there was no bone graft with the cartilage as it was designed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012263 |
| MDR Report Key | 125295 |
| Date Received | 1997-10-09 |
| Date of Report | 1997-09-30 |
| Date of Event | 1997-09-29 |
| Date Added to Maude | 1997-10-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNOVASIVE COR |
| Generic Name | HARVESTER FOR CARTILAGE BONE GRAFT |
| Product Code | GFI |
| Date Received | 1997-10-09 |
| Returned To Mfg | 1997-09-29 |
| Model Number | INNOVASIVE COR CUTTER 4MM |
| Catalog Number | 3513 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122654 |
| Manufacturer | INNOVASIVE DEVICES, INC. |
| Manufacturer Address | 734 FOREST ST MARLBOROUGH MA 01752 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-09 |