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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MÉDICAL EAS ALPHA SCREW D6.0MM L40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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LDR MÉDICAL EAS ALPHA SCREW D6.0MM L40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number N/A
Device Problems Suction Problem (2170); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2018
Event Type  Injury  
Manufacturer Narrative
Product was returned to manufacturer on june 12 th 2018. Non-compliance was confirmed. The product with the same batch number were put under containment. The 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. Additional informations were requested. Investigation still in progress.
 
Event Description
Easyspine : damaged packaging. A screw bag easyspine ( ref es 162 t and lot number 718145) found to have no vacuum the operative technician found that there was no vacuum before opening the plastic (idem: inflated plastic). Initially, the box was well packed with its crystal paper. Surgery was completed without any issue or impact on patient.
 
Event Description
Easyspine : damaged packaging. A screw bag easyspine found to have no vacuum. The operative technician found that there was no vacuum before opening the plastic. Initially, the box was well packed with its crystal paper. Surgery was completed without any issue or impact on patient reported. Product was received on june 12th 2018 and found to be non-compliant. The product was sent to the subcontractor for expertise and was found non-compliant with bubble test : there are some perforation on pouches (20th june) ( customer description was confirmed).
 
Manufacturer Narrative
The review of the device history records and traceability did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event. A visual examination was performed on product with the same lot number under manufacturer inventory. One product was found potentially non-complaint. It was then sent to the subcontractor with a sample of three product from the stock. A "buble test " was performed and the non-compliance was confirmed for the product that was initially identified in the manufacturer inventory and the three others products were found compliant. The non-compliant product shows the presence of bubble. Visual analysis reveals the presence of micro-perforations. A request for a root cause analysis and a proposal for a corrective action plan has been made to the subcontractor, hypotheses for the root cause/corrective action plan for this issue were provided by the supplier and the study of these hypotheses are in progress. Investigation still in progress. Conclusion not yet available.
 
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Brand NameEAS ALPHA SCREW D6.0MM L40MM
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 Key7831692
MDR Text Key119045121
Report Number3004788213-2018-00254
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2022
Device Model NumberN/A
Device Catalogue NumberES162T
Device Lot Number718145
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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