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U.S. Department of Health and Human Services

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

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OXFORD PERFORMANE MATERIALS, INC. HTR-PEKK CRANIAL IMPLANT, PRODUCT CODE: GXN Back to Search Results
Model Number PK623628
Device Problem Insufficient Information (3190)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/06/2020
Event Type  Injury  
Event Description
Implant was reordered to replace device that was or will be removed due to a bleed of some sort. No additional information is available at this time.
 
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Brand NameHTR-PEKK
Type of DeviceCRANIAL IMPLANT, PRODUCT CODE: GXN
Manufacturer (Section D)
OXFORD PERFORMANE MATERIALS, INC.
30 south satellite road
south windsor CT 06074
Manufacturer (Section G)
OXFORD PERFORMANCE 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 Key10992364
MDR Text Key220961155
Report Number3009582362-2020-00012
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810023927044
UDI-Public00810023927044
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 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPK623628
Device Lot Number209453
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2020
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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