OPTETRAK TIBIAL TRAY 200-04-33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-06-19 for OPTETRAK TIBIAL TRAY 200-04-33 manufactured by Exactech, Inc..

Event Text Entries

[5860537] Index surgery: (b)(6) 2010. Revision of optetrak knee components - reason not reported. This event occurred outside of the us, in (b)(6) and was discovered as part of active surveillance.
Patient Sequence No: 1, Text Type: D, B5


[13469079] The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation. Additionally, the device specific identification info was not provided, precluding a review of the device history record.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1038671-2015-00281
MDR Report Key4863074
Report Source07
Date Received2015-06-19
Date of Report2015-06-15
Date of Event2015-04-07
Date Mfgr Received2015-05-21
Date Added to Maude2015-07-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactGRAHAM CUTHBERT
Manufacturer Street2320 N.W. 66TH CT.
Manufacturer CityGAINESVILLE FL 32653
Manufacturer CountryUS
Manufacturer Postal32653
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTETRAK TIBIAL TRAY
Generic NameTIBIAL TRAY
Product CodeHSH
Date Received2015-06-19
Catalog Number200-04-33
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEXACTECH, INC.
Manufacturer Address2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-19

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