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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA UNKNOWN TRAUMA

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BIOMET TRAUMA UNKNOWN TRAUMA Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events. Event details and product identification were not provided for the patients mentioned in the journal article. The following sections could not be completed with the limited information provided. (b)(6).

 
Event Description

Information was received based on review of a journal article titled, "ball-joint versus single monolateral external fixators for definitive treatment of tibial shaft fractures" which aimed to compare a single, rigid, monolateral external fixator without ball-joints with a modular, less rigid monolateral external fixator with balljoints for the treatment of open and complex tibial shaft fractures. In the article, twenty-four patients were identified as experiencing pin tract infection, which was treated with antibiotics. There has been no further information provided and the patient outcome is unknown.

 
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Brand NameUNKNOWN TRAUMA
Manufacturer (Section D)
BIOMET TRAUMA
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw , IN 46582
5743726700
MDR Report Key5885675
Report Number0001825034-2016-03138
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 07/21/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
OTHER Device ID NumberN/A
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 Received07/21/2016
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
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/18/2016 Patient Sequence Number: 1
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