MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-04-04 for INDIANA TOME SYSTEM UNK manufactured by Biomet, Inc..
[812403]
Patient reported that during procedure using indiana tome system, the nerve in his left hand was cut. No further details have been provided.
Patient Sequence No: 1, Text Type: D, B5
[7990295]
Current information is insufficient to permit a conclusion as to the cause of the event. No further complications have been reported. There have been no trends identified related to this type of event. This report filed on april 4, 2008.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2008-00093 |
| MDR Report Key | 1025157 |
| Report Source | 04 |
| Date Received | 2008-04-04 |
| Date of Report | 2008-03-10 |
| Date Mfgr Received | 2008-03-10 |
| Date Added to Maude | 2008-04-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM WALGAMUTH, SPEC. |
| Manufacturer Street | PO BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET, INC. |
| Manufacturer Street | PO BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDIANA TOME SYSTEM |
| Product Code | EKD |
| Date Received | 2008-04-04 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992731 |
| Manufacturer | BIOMET, INC. |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 465810587 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-04-04 |