• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OXFORD PERFORMANCE MATERIALS HTR-PEKK CRANIAL IMPLANT Back to Search Results
Model Number PK621775
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
The implant was removed and replaced due to an infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8608075
MDR Text Key145010341
Report Number3009582362-2019-00006
Device Sequence Number1
Product Code GXN
UDI-Device Identifier00810042037960
UDI-Public00810042037960
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 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPK621775
Device Lot Number204578
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/11/2019
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: 05/14/2019 Patient Sequence Number: 1
-
-