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 20 FGT-20 manufactured by Ascension Orthopedics.
[77304885]
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
[77304886]
Two of 3 reports - other mfg report numbers: 1651501-2017-00021 / 1651501-2017-00023. It was reported a concern that the product was not sterile. The sterilization indicator label was yellow instead of green. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2017-00022 |
| MDR Report Key | 6624020 |
| 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 20 |
| Generic Name | TOE JOINT REPLACEMENT |
| Product Code | KWH |
| Date Received | 2017-06-08 |
| Catalog Number | FGT-20 |
| Lot Number | CT0116057 |
| 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 |