MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 15X17 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Limited Mobility Of The Implanted Joint (2671); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer.As it's still implanted.Two mobi-c references were identified for the first surgery.Not enough information provided to identify which device was implanted in c6-c7.So a report was created for each implant.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 the reporter.Conclusion is not yet available.Investigation still in progress.Device remain implanted.

Event Description

Mobi-c p&f us : migration.It was reported that a patient had a two levels mobi-c implantation.From description received, the devices looked great for immediate post-op.Initial surgery date: (b)(6) 2017.Then it was noticed after that one of the implant had migrated at c6-7.Patient is asymptomatic and surgeon hasn't decided yet if a revision is needed.The first analysis of the images provided shows that the prosthesis probably lost its mobility.Update received on april 5th 2018 : the patient didn¿t have any trauma the reporter thinks that the patient did not have too much motion after the initial surgery.The reporter don't believe there are dynamic images of the patient.Update on 6th april 2018: two mobi-c references were identified for the first surgery.Not enough information provided to identify which device was implanted in which level.Investigation still in progress.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation.Fields date of report, event, concomitant medical products, and device evaluated by mfrwere updated.Product was not returned for examination as they still implanted.No information about a revision scheduled as the patient is symptom free.The review of the traceability and the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.This case was reported about a c6-c7 migration post op and two reference of implants were communicated.However , no clarification was received on which prothesis was implanted in which level.Severals attempts were sent to the reporter to have additional information , no update received.The review of this case with product range manager , the x-rays evaluation and based on the product history records , the investigation found no evidence on a device issue.The exact root cause remain undetermined with hypothesis of migration caused by excessive compression after implant insertion.As mentioned in surgical technique step 16 : once final position is confirmed, apply firm compression using the caspar distractor to seat the implant teeth into the vertebrae.In a two-level case, perform compression at each level separately.Investigation found no evidence on a device issue.If additional informations were received that add a value on this case , another report will be sent.

Event Description

Mobi-c p&f us : migration.It was reported that a patient had a two levels mobi-c implantation.From description received, the devices looked great for immediate post-op.Initial surgery date: on (b)(6) 2017.Then it was noticed after that one of the implant had migrated at c6-7.Patient is asymptomatic and surgeon hasn't decided yet if a revision is needed.The first analysis of the images provided shows that the prosthesis probably lost its mobility.Additional informations received : the patient didn¿t have any trauma.The reporter thinks that the patient did not have too much motion after the initial surgery.No dynamic pictures were provided.Two mobi-c references were identified for the first surgery.Not enough information provided to identify which device was implanted in which level.Severals attempts were made to collect additional informations on this case.No update received from the reporter.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X17 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: 7486071
• MDR Text Key: 107316717
• Report Number: 3004788213-2018-00136
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5285798
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1