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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 PK621096
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event Serious Injury
Event or Problem Description
The sales associate requested a re-make of pk621096 due to a re-operation.The patient had a csf leak due to damage to the dura.Upon follow-up with the sales associate, it was confirmed that there was no alleged failure of the implant to perform as intended and no indication that the implant contributed to the need for the re-operation.During the original implant procedure on (b)(6) 2018 it was noted that the patient's dura was not intact.
 
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Brand Name
HTR-PEKK
Common Device Name
CRANIAL IMPLANT
Manufacturer (Section D)
OXFORD PERFORMANCE MATERIALS
po box 585
30 south satellite road
south windsor CT 06074
MDR Report Key7884936
Report Number3009582362-2018-00007
Device Sequence Number18889256
Product Code GXN
UDI-Device Identifier00810042034914
UDI-Public00810042034914
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K121818
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Model NumberPK621096
Device Lot Number202933-001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/22/2018
Initial Report FDA Received Date09/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age60 YR
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