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U.S. Department of Health and Human Services

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

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OXFORD PERFORMANCE MATERIALS HTR-PEKK CRANIAL IMPLANT Back to Search Results
Model Number PK620744
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Edema (1820)
Event Type  Injury  
Event Description
The patient had to return to the operating surgeon several times due to fluid build up. The device remains implanted.
 
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Brand NameHTR-PEKK
Type of DeviceCRANIAL 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 Key8703813
MDR Text Key148164872
Report Number3009582362-2019-00008
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810042033405
UDI-Public00810042033405
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 Non-Healthcare Professional
Type of Report Initial
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPK620744
Device Lot Number202075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/24/2018
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: 06/17/2019 Patient Sequence Number: 1
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