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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE DFL

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I.T.S. GMBH DISTAL FEMUR PLATE DFL Back to Search Results
Model Number 21302-9
Device Problem Missing Value Reason (3192)
Patient Problem Missing Value Reason (3192)
Event Date 04/05/2017
Event Type  Injury  
Manufacturer Narrative

First investigation was performed, checking the quality inspection forms as well as the material certificates and no deviation was detected. As soon we receive the device back, further investigation is performed. We have not received the device now.

 
Event Description

We received the information concerning a broken distal femur plate. The report of the sales rep, who discussed the issue with the surgeon, states that the bone did not consolidate in an effective manner, with a bone gap evident at one of the fracture sites, with sclerotic bone edges evident. These findings were discussed with the head surgeon and the conclusion was the diagnosis of a non-union. Two out of three fracture section healed in a proper way and one presented a non-union.

 
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Brand NameDISTAL FEMUR PLATE
Type of DeviceDFL
Manufacturer (Section D)
I.T.S. GMBH
autal 28
lassnitzhöhe, styria 8301
AU 8301
Manufacturer (Section G)
I.T.S. GMBH
autal 28
lassnitzhöhe, styria 8301
AU 8301
Manufacturer Contact
florian grill
autal 28
lassnitzhöhe, styria 8301
AU   8301
3316211214
MDR Report Key6676245
MDR Text Key78652908
Report Number3004369035-2017-00003
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number21302-9
Device Catalogue Number21302-9
Device LOT Number20/150758
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/29/2017 Patient Sequence Number: 1
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