MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-08 for NEXA FGT IMPLANT SIZE 50 FGT-50 manufactured by Ascension Orthopedics.
[77423495]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[77423496]
One (1) of 3 reports - other mfg report numbers: 1651501-2017-00022 / 1651501-2017-00023. It was reported that the device was implanted and the sterilization sticker was yellow instead of green. They did some further investigating and removed the top label to find another label underneath that stated the product expired in 2011. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2017-00021 |
| MDR Report Key | 6623660 |
| Date Received | 2017-06-08 |
| Date of Report | 2017-05-18 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-06-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEXA FGT IMPLANT SIZE 50 |
| Generic Name | TOE JOINT REPLACEMENT |
| Product Code | KWH |
| Date Received | 2017-06-08 |
| Catalog Number | FGT-50 |
| Lot Number | CT0416057 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-08 |