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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 PK6620279
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 02/07/2018
Event Type  Injury  
Event Description
The distributor reported a revision request due to an infection.The distributor stated the surgeon removed the implant because of the infection, but nothing was wrong with the implant.
 
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Brand Name
HTR-PEKK
Type of Device
CRANIAL 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 Key7311105
MDR Text Key101464186
Report Number3009582362-2018-00002
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810042031364
UDI-Public00810042031364
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 Other
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberPK6620279
Device Lot Number201280-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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