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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE ENDOTINE FIXATION DEVICE

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MICROAIRE SURGICAL INSTRUMENTS MICROAIRE ENDOTINE FIXATION DEVICE Back to Search Results
Model Number CFD-22102
Device Problems Component Missing (2306); Device Packaging Compromised (2916); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2015
Event Type  Malfunction  
Manufacturer Narrative

Due to indication of only one device in box, which caused a slight delay in surgery, it was determined that this event is reportable.

 
Event Description

The customer reported that there was only one implant in the box. The product is packaged as a two (2) pack. The shortage resulted in a slight delay in surgery.

 
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Brand NameMICROAIRE ENDOTINE
Type of DeviceFIXATION DEVICE
Manufacturer (Section D)
MICROAIRE SURGICAL INSTRUMENTS
3590 grand forks boulevard
charlottesville VA 22911
Manufacturer (Section G)
MICROAIRE SURGICAL INSTRUMENTS
3590 grand forks boulevard
charlottesville VA 22911
Manufacturer Contact
donna elliott
3590 grand forks boulevard
charlottesville, VA 22911
4349758370
MDR Report Key5127340
MDR Text Key27809840
Report Number2020601-2015-00080
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK032770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date11/30/2017
Device MODEL NumberCFD-22102
Device Catalogue NumberCFD-22102
Device LOT Number260409
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 Received09/09/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/08/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/05/2015 Patient Sequence Number: 1
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