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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL EASYSPINE THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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LDR MÉDICAL EASYSPINE THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 07/19/2017
Event Type  Injury  
Manufacturer Narrative
Attempts have been made and no further information has been provided without any product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. Then root cause of this event is unknown.
 
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
Easyspine : revision. Removal of easyspine system with no information about the reason of the revision ref and lots of products were not communicated. Additional information was requested.
 
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Brand NameEASYSPINE
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR 10300
Manufacturer (Section G)
LDR MÉDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR 10300
Manufacturer Contact
florence chapaud
quartier europe de l¿ouest
5, rue de berlin
sainte-savine 10300
FR   10300
3310648075
MDR Report Key6816869
MDR Text Key113677213
Report Number3004788213-2017-00053
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
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 Received07/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/24/2017 Patient Sequence Number: 1
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