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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 Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2018
Event Type  malfunction  
Manufacturer Narrative
No investigation possible to date of initial report. Product was returned to the manufacturer. However , the package state prevent from confirming the issue or from recreating the event. 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 information was requested investigation still in progress.
 
Event Description
Easyspine: damaged packaging a problem with a box of pedicle screws 6. 40 alpha ref es162t: the plastic bag containing the screws was not under vacuum. Product received : on june 8th 2018 (without decontamination form). The bag has been damaged no confirmation of possible issue could be made. The condition of the product does not allow confirmation of the observed discrepancy. Additional informations requested. Investigation still in progress.
 
Manufacturer Narrative
The review of the device history records did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event. Another case related to the same bag (same ref/lot, in the same health care center) was identified on (b)(6) and issue confirmed on june 12th after the bag was received by the manufacturer (this case is treated with another report cmp (b)(4)). 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.
 
Event Description
Easyspine : damaged packaging. It was reported from the hospital on (b)(6) 2018: " we had a problem with a box of pedicle screws 6. 40 alpha ref es162t: the plastic bag containing the screws was not under vacuum. " according to the reporter: initially, the box was well packed with its crystal paper. Surgery was completed without any issue or impact on patient reported. Product received: on (b)(6) 2018 (without decontamination form). However, the plastic bag that contain the easyspine screw was already opened which prevent from inspecting the issue and confirming it.
 
Manufacturer Narrative
This medwatch is submitted to send the result of the investigation of this complaint. The review of the device history records did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event. Based on the available information, the exact root cause of the event remain undetermined, with two potential hypothesis: it is possible that the pouch were damaged when inserting the parts inside the bags. Aggressive parts could weaken the bags before sealing and vacuuming. The non-conformity could have been occurred during the transport. An internal corrective action was initiated to identify the exact root cause and to enforce the adequate actions. It's important to highlight that defect can is highly detectable during the implant opening. In addition , the blister consist as second sterile barrier. Moreover , the ifu indicate that the packaging must be controlled before use and if issue can be detected, the product must not be used. The exact root cause of this event remain undetermined, however if additional informations were received that allow to validate a conclusion, another report will be sent.
 
Event Description
Easyspine: damaged packaging. It was reported from the hospital on (b)(6) 2018 : we had a problem with a box of pedicle screws 6. 40 alpha ref es162t: the plastic bag containing the screws was not under vacuum. According to the reporter: initially, the box was well packed with its crystal paper. Surgery was completed without any issue or impact on patient reported. Product received: on june 8th 2018 (without decontamination form). However, the plastic bag that contain the easyspine screw was already opened which prevent from inspecting the issue and confirming it.
 
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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 Key7831687
MDR Text Key119072399
Report Number3004788213-2018-00252
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 12/05/2018
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 Received04/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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