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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL ELEMENTS, INC. MERCURY CLASSIC MERCURY STRAIGHT ROD 5.5MM X 400MM

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SPINAL ELEMENTS, INC. MERCURY CLASSIC MERCURY STRAIGHT ROD 5.5MM X 400MM Back to Search Results
Device Problems Fracture (1260); Misconnection (1399)
Patient Problem No Information (3190)
Event Date 03/21/2017
Event Type  Injury  
Manufacturer Narrative

Patient kept device.

 
Event Description

Revision surgery performed to remove mercury straight rod 400mm that had fractured between l1 and l2 at the interface with the rod-to-rod connectors. Original surgery took place in (b)(6) 2016 with an unsuccessful fusion.

 
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Brand NameMERCURY CLASSIC
Type of DeviceMERCURY STRAIGHT ROD 5.5MM X 400MM
Manufacturer (Section D)
SPINAL ELEMENTS, INC.
3115 melrose drive, suite 200
carlsbad CA 92010
Manufacturer Contact
julie lamothe
3115 melrose drive, suite 200
carlsbad, CA 92010
7606071816
MDR Report Key6481803
MDR Text Key72797853
Report Number3004893332-2017-00007
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 04/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/27/2017
Event Location No Information
Date Manufacturer Received03/27/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/11/2017 Patient Sequence Number: 1
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