MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Product was scrapped at the hospital.Therefore, no product evaluation could be performed.Attempt has been made to the reporter to collect additional information concerning the reported event.Yet, no answer has been received yet.Investigation is still in progress.Conclusion is not yet available.

Event Description

Mobi-c p&f us: implant seemed loose.According to the reporter: mobi-c surgical technique was followed and when the implant was handed to surgeon for implantation he stated that it seemed loose.A new implant of the same size was opened.No harm to the patient.No delay.Additional information received on february 28th 2019: the current patient's state of health is good.The issue occurred before implantation.The depth stop adjustment was initially set at zero.The surgical technique at the mobi-c loading on inserter (take care to stop threading as soon as full contact is achieved in order to avoid premature opening of the peek cartridge and releasing the implant) was followed.No differences in surgical steps between the first and the second implant were noticed.No picture available.The reporter did not know who loaded the implant on the inserter and whether or not this person had already done it.Attempt has been made to collect additional information concerning the reported event to the reporter.Yet, no answer has been received yet.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint following the additional information received.Fields b4, b5, g4, g7, h2, h5, h6 and h10 were updated.Product was scrapped at the hospital.Therefore, no product evaluation could be performed.From the information provided based on the complaint report and the product history records review, the investigation found no evidence to indicate a device related issue.It is clearly stated in the surgical technique that it is normal to have a little movement in the implant attachment to the peek cartridge, particularly in the superior endplate (step 9: implant assembly to the implant inserter).Moreover, without the product return and evaluation, this issue cannot be confirmed.The investigation found no evidence to indicate a device related issue.If additional information was received that add a value on this investigation result , another report will be sent.

Event Description

Mobi-c p&f us : implant seemed loose.A distributor reported on february 06th 2018 that the mobi-c surgical technique was followed and when the implant was handed to surgeon for implantation he stated that it seemed loose and requested a different implant be opened.Additional information received on february 28th 2019: the current patient's state of health is good.The issue occurred before implantation.The depth stop adjustement was initially set at zero.The surgical technique at the mobi-c loading on inserter (take care to stop threading as soon as full contact is achieved in order to avoid premature opening of the peek cartridge and releasing the implant) was followed.No differences in surgical steps between the first and the second implant were noticed.No pictures of defective product before hospital scrapped it are available.The reporter did not know who loaded the implant on the inserter and whether or not this person had already done it.Additional information received on march 11th 2019: the issue occurred after assembling the implant to the inserter.The word up could be read on the inserter.The reporter did not have the reference and lot number of the inserter used during the surgery.The implant did not disassemble.According to the reporter, it is always possible that the inserter was over tightened.The reporter could not confirm that the inserter was over tightened.The part of the implant that seemed loose was the endplates.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8390734
• MDR Text Key: 137838190
• Report Number: 3004788213-2019-00049
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5307243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 59 YR