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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 PK618173
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Post Operative Wound Infection (2446)
Event Date 01/04/2017
Event Type  No Answer Provided  
Event Description
The implant was removed due to an infection. The cause or the source of the infection are unknown. The implant is shipped non-sterile and then sterilized at the healthcare facility according to the instructions for use. There are no sterilization, pathology, or surgical records available.
 
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Brand NameHTR-PEKK
Type of DeviceCRANIAL IMPLANT
Manufacturer (Section D)
OXFORD PERFORMANCE MATERIALS, INC.
p.o. box 585
30 south satellite road
south windsor CT 06074
Manufacturer (Section G)
OXFORD PERFORMANCE MATERIALS, INC.
p.o. box 585
30 south satellite road
south windsor CT 06074
Manufacturer Contact
leigh ayres
p.o. box 585
30 south satellite road
south windsor, CT 06074
8606989300
MDR Report Key6264482
MDR Text Key65345004
Report Number3009582362-2017-00001
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00813298023831
UDI-Public00813298023831
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 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberPK618173
Device Lot NumberIG5775M-11F001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/14/2016
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: 01/19/2017 Patient Sequence Number: 1
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