Brand Name | HTR-PEKK |
Type of Device | CRANIAL IMPLANT |
Manufacturer (Section D) |
OXFORD PERFORMANCE MATERIALS |
po box 585 |
30 south satellite road |
south windsor CT 06074 |
|
Manufacturer (Section G) |
OXFORD PERFORMANCE MATERIALS |
po box 585 |
30 south satellite road |
south windsor CT 06074 |
|
Manufacturer Contact |
beth
pashko
|
po box 585 |
30 south satellite road |
south windsor, CT 06074
|
8606569450
|
|
MDR Report Key | 9664987 |
MDR Text Key | 177803851 |
Report Number | 3009582362-2020-00002 |
Device Sequence Number | 1 |
Product Code |
GXN
|
UDI-Device Identifier | 00810042039773 |
UDI-Public | 00810042039773 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121818 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/04/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | PK622132 |
Device Lot Number | 205524 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/21/2020 |
Initial Date FDA Received | 02/04/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/30/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 49 YR |
|
|