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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN_FRO_PRODUCT IMPLANT

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STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN_FRO_PRODUCT IMPLANT Back to Search Results
Catalog Number UNK_FRO
Device Problems Detachment Of Device Component (1104); Fitting Problem (2183)
Patient Problem Failure of Implant (1924)
Event Date 03/30/2017
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 was discarded by the user facility.
 
Event Description
A sales representative stated that a medpor implant was removed due to a poor fit to the patient. Upon removal of the implant, the surgeon noted that the medpor plastic was becoming detached from the titanium. The patient had a revision surgery due to the alleged poor fit of the device.
 
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Brand NameUNKNOWN_FRO_PRODUCT
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
hans geiger
boetzingerstr. 41
freiburg D-791-11
76145120
MDR Report Key6595311
MDR Text Key76094472
Report Number0008010177-2017-00116
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 05/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_FRO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
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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