MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-17 for INDIANA TOME 200060 manufactured by Biomet, Inc..
| Report Number | 1825034-1998-00054 |
| MDR Report Key | 173241 |
| Report Source | 05 |
| Date Received | 1998-06-17 |
| Date of Report | 1998-06-17 |
| Date of Event | 1998-02-09 |
| Date Mfgr Received | 1998-05-18 |
| Date Added to Maude | 1998-06-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDIANA TOME |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL |
| Product Code | EKD |
| Date Received | 1998-06-17 |
| Model Number | NA |
| Catalog Number | 200060 |
| Lot Number | UNK |
| ID Number | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 161262 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | PO BOX 587 WARSAW IN 465810587 US |
| Baseline Brand Name | INDIANA TOME |
| Baseline Generic Name | INSTRUMENT, MANUAL, SURGICA |
| Baseline Model No | NA |
| Baseline Catalog No | 200060 |
| Baseline ID | NA |
| Baseline Device Family | INDIANA TOME |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-06-17 |