SUBTALAR MBA IMPLANT 14MM 050114

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-08-11 for SUBTALAR MBA IMPLANT 14MM 050114 manufactured by Integra, Cincinnati.

Event Text Entries

[2268606] The reporter stated that the patient was anesthetized for a surgical procedure to implant the subtalar mba system (indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint). The surgeon requested a size 14 mm implant. The products available in the hospital inventory had an expiration date of june 30, 2011. The surgery was done on (b)(6) 2011. The user facility elected to reprocess the products in the hospital autoclave (with biological indicators) in accordance with joint commission protocols. There has been no adverse outcome for the patient to date. The products had been part of the hospital's own inventory.
Patient Sequence No: 1, Text Type: D, B5


[9257459] The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004608878-2011-00113
MDR Report Key2222539
Report Source05,07
Date Received2011-08-11
Date of Report2011-08-11
Date Mfgr Received2011-07-29
Date Added to Maude2012-03-30
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 ContactSUSAN SCOTT
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099363604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUBTALAR MBA IMPLANT 14MM
Generic NameNA
Product CodeMJW
Date Received2011-08-11
Catalog Number050114
Lot Number7603-14-10321
Device Expiration Date2011-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA, CINCINNATI
Manufacturer AddressCINCINNATI OH 45227 US 45227


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-08-11

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