MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-10-20 for VISIONAIRE V0100021 manufactured by Brooks Manufacturing Site.
[1303941]
It has been reported that surgery time was extended. The surgeon felt that the tibial cutting block did not fit properly. The surgeon recut the tibia, and used a p/s insert for better stability.
Patient Sequence No: 1, Text Type: D, B5
[8286652]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2009-00731 |
| MDR Report Key | 1512601 |
| Report Source | 07 |
| Date Received | 2009-10-20 |
| Date of Report | 2009-10-19 |
| Date of Event | 2009-09-29 |
| Date Mfgr Received | 2009-09-30 |
| Device Manufacturer Date | 2009-09-17 |
| Date Added to Maude | 2009-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. LEAH EASLEY |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996137 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIONAIRE |
| Generic Name | CUTTING BLOCK / EKD |
| Product Code | IQO |
| Date Received | 2009-10-20 |
| Returned To Mfg | 2009-10-12 |
| Model Number | NA |
| Catalog Number | V0100021 |
| Lot Number | PM002504V2 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BROOKS MANUFACTURING SITE |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-10-20 |