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

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.

• Brand Name: EAS ALPHA SCREW D6.0MM L40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7831687
• MDR Text Key: 119072399
• Report Number: 3004788213-2018-00252
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: ES162T
• Device Lot Number: 718145
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 04/23/2018
• Supplement Dates FDA Received: 10/11/2018; 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1