MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-01-13 for EX-FIX 103451 manufactured by Smith Nephew Inc..
[1275531]
It was reported that a revision surgery was required due to a broken rancho cube.
Patient Sequence No: 1, Text Type: D, B5
[8492801]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2010-00007 |
| MDR Report Key | 1578057 |
| Report Source | 07 |
| Date Received | 2010-01-13 |
| Date of Report | 2010-01-13 |
| Date of Event | 2009-12-07 |
| Date Mfgr Received | 2009-12-18 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2010-01-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CHADWICK BROWN |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995182 |
| Manufacturer G1 | SMITH NEPHEW INC. |
| Manufacturer Street | 1450 BROOKS RD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EX-FIX |
| Generic Name | RANCHO CUBE / LYT |
| Product Code | LYT |
| Date Received | 2010-01-13 |
| Catalog Number | 103451 |
| Lot Number | 08MM09712 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH NEPHEW INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-01-13 |