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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL PEDICLE SCREW 6 MM L 40 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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LDR MÉDICAL PEDICLE SCREW 6 MM L 40 MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number N/A
Device Problem Fitting Problem (2183)
Patient Problem No Code Available (3191)
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative
Product was not returned to manufacturer. No examination could be performed. The review of the traceability and device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event additional information were requested to reporter. Conclusion is not yet available. Investigation still in progress.
 
Event Description
Easyspine : screw diameter not fit. According to the reporter : "screw diameter 6 mm too narrow therefore change to 7 mm. No consequences for the patient because the screws in diameter 7 have been implanted" additional information were requested. Investigation in progress.
 
Manufacturer Narrative
Without a product return, no product evaluation can be conducted. Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event. As reported : screw diameter 6mm too narrow so change to 7mm no consequences for the patient because the screws in diameter 7 have been installed. No other information provided. Regarding information provided, root cause is related to an user error. The investigation found no evidence to indicate a device issue. 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.
 
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Brand NamePEDICLE SCREW 6 MM L 40 MM
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
MDR Report Key7486037
MDR Text Key107315613
Report Number3004788213-2018-00138
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2022
Device Model NumberN/A
Device Catalogue NumberES162T
Device Lot Number702236
Other Device ID NumberN/A
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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