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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI 60MM TI CURVED ROD

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BIOMET SPINE - BROOMFIELD POLARIS 5.5 TI 60MM TI CURVED ROD Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Manufacturer Narrative

The implants are titanium alloy. The user facility is foreign; therefore a facility medwatch report will not be available. Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Report five of five for the same event; see also 3004485144-2016-00054 through 00057. Remains implanted.

 
Event Description

The sales associate reported that a patient underwent a surgery in 2012 in which a polaris was implanted. An allergy to some components such as cobalt chloride, golden sodium bisulfite and nickel has been detected to the patient. It is reported no revision surgery is planned at this time and the surgeon does not think the patient's symptoms are related to the implants.

 
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Brand NamePOLARIS 5.5 TI 60MM TI CURVED ROD
Type of DeviceROD
Manufacturer (Section D)
BIOMET SPINE - BROOMFIELD
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer (Section G)
BIOMET SPINE - BROOMFIELD
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer Contact
michelle cole
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key5619382
MDR Text Key44009223
Report Number3004485144-2016-00058
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number2000-5160
Device LOT NumberUNKNOWN
OTHER Device ID NumberN/A
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 Received03/30/2016
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 Unkown
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/29/2016 Patient Sequence Number: 1
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