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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 PK620002
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
The distributor reported that the implant had been removed due to a scalp infection.
 
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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 Key7741912
MDR Text Key115774229
Report Number3009582362-2018-00006
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810042030077
UDI-Public00810042030077
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 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPK620002
Device Lot Number200568-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/19/2017
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: 08/02/2018 Patient Sequence Number: 1
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