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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MEDPOR TITAN SHEET - MTB - 38M IMPLANT

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STRYKER LEIBINGER FREIBURG MEDPOR TITAN SHEET - MTB - 38M IMPLANT Back to Search Results
Catalog Number 81026
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Irritation (1941)
Event Date 12/02/2016
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device remains implanted.
 
Event Description
It was reported that the physician stated the patient came in with inflammation and irritation around the eye where the product was implanted. No replacement was needed at the time and the product will not be returned. Also, it is unknown if the implant is the cause of the inflammation. No other information is available at this time.
 
Manufacturer Narrative
Been updated based on new information received.
 
Event Description
It was reported that the physician stated the patient came in with inflammation and irritation around the eye where the product was implanted. No replacement was needed at the time and the product will not be returned. Also, it is unknown if the implant is the cause of the inflammation. It was recently discovered that steroids were administered to the patient to treat the redness and swelling.
 
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Brand NameMEDPOR TITAN SHEET - MTB - 38M
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER LEIBINGER FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer (Section G)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer Contact
hans geiger
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key6210447
MDR Text Key63810993
Report Number0008010177-2016-00305
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number81026
Device Lot Number81510036
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 Received12/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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