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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR TITAN SHEET - BTB - 38M IMPLANT

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STRYKER ORTHOBIOLOGICS-MALVERN MEDPOR TITAN SHEET - BTB - 38M IMPLANT Back to Search Results
Catalog Number 81024
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Date 04/25/2016
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 not available for return.
 
Event Description
It was reported that a surgeon removed the implant because the surgeon thought that the patient was allergic to the implant.
 
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Brand NameMEDPOR TITAN SHEET - BTB - 38M
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer (Section G)
STRYKER ORTHOBIOLOGICS-MALVERN
45 great valley parkway
malvern PA 19355
Manufacturer Contact
jonathan schell
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key5721061
MDR Text Key47284431
Report Number0008010177-2016-00124
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
Report Date 05/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number81024
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
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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