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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK CRANIAL IMLANT, PRODUCT CODE: GXN

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OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK CRANIAL IMLANT, PRODUCT CODE: GXN Back to Search Results
Model Number PK623398
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 08/19/2020
Event Type  Injury  
Event Description
It was reported that the healthcare facility needed a new implant due to an infection.
 
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Brand NameHTR-PEKK
Type of DeviceCRANIAL IMLANT, PRODUCT CODE: GXN
Manufacturer (Section D)
OXFORD PERFORMANCE MATERIALS, INC.
30 south satellite road
south windsor, ct
Manufacturer (Section G)
OXFORD PERFORMANCE MATERIALS, INC.
30 south satellite road
south windsor, ct
Manufacturer Contact
james porteus
30 south satellite road
south windsor, ct 
6569438
MDR Report Key10507898
MDR Text Key206150970
Report Number3009582362-2020-00009
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810023925750
UDI-Public00810023925750
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPK623398
Device Lot Number209000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/09/2020 Patient Sequence Number: 1
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