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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 Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2007
Event Type  malfunction  
Manufacturer Narrative
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. After several attempts, we have insufficient information to determine if the implant is available for return.
 
Event Description
It was reported that an additional surgery was required due to the medpor titan implant posterior resting.
 
Manufacturer Narrative
Although the complained implant has not been returned, the reported event could be confirmed, because a picture that shows the failure was provided. The complained event has been discussed with the related r&d department, which got in contact with 2 surgeons of the related paper. The following was provided by the r&d department: this appears to be a case where the surgeon did not place the implant correctly, or bent it too much before placement so that the posterior edge was too high, or possibly that the implant moved or ¿rocked¿, (displaced slightly inferiorly on the anterior edge so that the posterior edge moved superiorly) after it was placed. Based on the statistical evaluation no indications for any design, material or manufacturing related problems were found in this investigation. Therefore no corrective and/or preventive actions are deemed necessary at this time.
 
Event Description
It was reported that an additional suregery was required due to the medpor titan implant posterior resting.
 
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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 Key5689386
MDR Text Key47332457
Report Number0008010177-2016-00113
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 02/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_FRO
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 Received05/04/2016
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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