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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK PS TIBIAL INSERT

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EXACTECH, INC. OPTETRAK PS TIBIAL INSERT Back to Search Results
Catalog Number 204-22-09
Device Problem Device Slipped (1584)
Patient Problem No Code Available (3191)
Event Date 02/13/2012
Event Type  Other  
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the device were not available for evaluation. A review of the device history record provides assurance the part was accepted with conformance to the product requirements.
 
Event Description
Revision of optetrak components due to tibial subsidence. This event occurred in (b)(6).
 
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Brand NameOPTETRAK
Type of DevicePS TIBIAL INSERT
Manufacturer (Section D)
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville FL 32653
Manufacturer Contact
melissa christensen
2320 n.w. 66th ct.
gainesville, FL 32653
8003922832
MDR Report Key2703770
MDR Text Key10169871
Report Number1038671-2012-00109
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/01/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number204-22-09
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/28/2012
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

Patient Treatment Data
Date Received: 08/01/2012 Patient Sequence Number: 1
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