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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK CRANIAL IMPLANT

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OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK CRANIAL IMPLANT Back to Search Results
Model Number PK623206
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 08/31/2020
Event Type  Injury  
Event Description
Implant was reordered and it was indicated that the first implant was removed due to a possible infection.
 
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Brand NameHTR-PEKK
Type of DeviceCRANIAL IMPLANT
Manufacturer (Section D)
OXFORD PERFORMANCE MATERIALS, INC.
30 south satellite road
south windsor CT 06074
Manufacturer (Section G)
OXFORD PERFORMANE MATERIALS, INC.
30 south satellite road
south windsor CT 06074
Manufacturer Contact
james porteus
30 south satellite road
south windsor, CT 06074
8606569438
MDR Report Key10508475
MDR Text Key206157476
Report Number3009582362-2020-00010
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810023924968
UDI-Public00810023924968
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 09/09/2020
1 Device was Involved in the Event
0 Patients were 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 NumberPK623206
Device Lot Number208680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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