MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-04 for HTR-PEKK PK622132 manufactured by Oxford Performance Materials.
[177803851]
The implant was re-manufactured due to an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009582362-2020-00002 |
| MDR Report Key | 9664987 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-05-30 |
| Date Added to Maude | 2020-02-04 |
| 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 | BETH PASHKO |
| Manufacturer Street | PO BOX 585 30 SOUTH SATELLITE ROAD |
| Manufacturer City | SOUTH WINDSOR CT 06074 |
| Manufacturer Country | US |
| Manufacturer Postal | 06074 |
| Manufacturer Phone | 8606569450 |
| Manufacturer G1 | OXFORD PERFORMANCE MATERIALS |
| Manufacturer Street | PO BOX 585 30 SOUTH SATELLITE ROAD |
| Manufacturer City | SOUTH WINDSOR CT 06074 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTR-PEKK |
| Generic Name | CRANIAL IMPLANT |
| Product Code | GXN |
| Date Received | 2020-02-04 |
| Model Number | PK622132 |
| Lot Number | 205524 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OXFORD PERFORMANCE MATERIALS |
| Manufacturer Address | PO BOX 585 30 SOUTH SATELLITE ROAD SOUTH WINDSOR CT 06074 US 06074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |