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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL SURGICAL STRATEGIES GRAFT FIRST

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SPINAL SURGICAL STRATEGIES GRAFT FIRST Back to Search Results
Catalog Number 00010
Device Problems Structural Problem (2506); Packaging Problem (3007)
Patient Problem No Code Available (3191)
Event Date 12/01/2016
Event Type  Other  
Event Description
Upon placing pressure on the device to place bone graft between the disc space, the product opened at the tip and the marking bead mixed with the graft. It was deemed safer to leave the marker than to retrieve it.
 
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Brand NameGRAFT FIRST
Type of DeviceGRAFT FIRST
Manufacturer (Section D)
SPINAL SURGICAL STRATEGIES
incline village NV 89451
MDR Report Key6166301
MDR Text Key62389506
Report NumberMW5066631
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Catalogue Number00010
Device Lot Number9434885
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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