2G OTOMIMIX N/A 7014-3266

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-08-14 for 2G OTOMIMIX N/A 7014-3266 manufactured by Biomet Microfixation.

Event Text Entries

[4688935] A hospital experienced a significant delay in surgery due to mimix not setting properly.
Patient Sequence No: 1, Text Type: D, B5


[11954287] There are no prior similar complaints reported with this product type causing a significant delay in surgery. The user facility indicated that the bone cement was discarded intraoperatively as was the packaging so no product is able to be returned to the manufacturer for evaluation. Length of surgical delay of 1 hour is attributed to two units, not a single. The customer indicates that the mixture did not set as intended. The instructions for use indicates proper mixing and setting times. It cannot be verified if these conditions were followed by the user facility. Review of device history records show that lot released with no recorded anomaly or deviation. The warnings in the package insert state this type of event can occur. The user facility is foreign; therefore a facility medwatch report will not be available. 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. This event occurred in (b)(6). Distributed quantities for this product for the past 4 years are as follows: 2011 = 3200, 2012 = 2700, 2013 = 3368, 2014 (to date) = 1500. File 2 of 2.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001032347-2014-00245
MDR Report Key4007886
Report Source01,07
Date Received2014-08-14
Date of Report2014-07-21
Date of Event2014-07-10
Date Mfgr Received2014-07-21
Device Manufacturer Date2012-09-01
Date Added to Maude2014-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMRS. AMANDA SISK
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand Name2G OTOMIMIX
Generic NameBONE CEMENT
Product CodeNEA
Date Received2014-08-14
Model NumberN/A
Catalog Number7014-3266
Lot Number954170
ID NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2014-08-14

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