MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C P&F US IMPLANT; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report.The review of the device history records and traceability could not be performed as no information concerning the reported implant (reference and lot number) has been provided for the moment.Attempt has been made 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.Device retained by patient.

Event Description

Mobi-c p&f us: revision + insert sheared off.According to the reporter: when removing the mobi-c implant during revision, the doctor noticed that the polyethylene mobile insert was displaced from the implant and sheared off.Thus creating the disc space to compress.X-rays and images were provided.Implant replaced by acdf.It was also reported by reporter on (b)(6) 2019: the reporter did not know the reference and lot number of the implant.The reason of revision was patient was suffering from arm pain.The reporter did not know if the surgeon found the missing part of the mobile insert.The original surgery was performed by dr.(b)(6) at (b)(6) medical.The device was implanted approximately 2 years.The patient is not a smoker.No patient trauma or accident was reported.Attempt has been made to collect additional information concerning the reported event.Yet, no answer has been received yet.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation the review of the device history records and traceability could not be performed as no information concerning the explanted prothesis were provided.The implant was retained by patient.Therefore, no product evaluation could be performed.From the information provided based on the complaint description and the recurrence of this type of event for this product, the investigation couldn't find any evidence to indicate a device issue.Based on the provided xrys ( pre revision operation dated on june 2017) , it's show that the implant was placed too anterior.Therefore , this may reflect a poor disc preparation and lack of distraction during the initial surgery.As mentioned in the surgical techniques ( (step 3 : parallel distraction, step 5: depth measurement , step 6 and step 12: position verification lateral view), it's important to apply the different steps of disc space distraction, depth measurement, trial selection and position verification to have an appropriate prothesis size and positioning in the disc space and to prevent the malpositioning issue.Based on the available information , this event is probably due to a poor disc space preparation in the first surgery.However , regarding the absence of information on the initial surgery and the absence of examination of the actual device , this conclusion cannot be confirmed.If additional informations were received another report will be sent.

Event Description

Mobi-c p&f us: revision and insert sheared off.Information was received about a mobi-c p&f us revision due to patient pain.The distributor reported that when removing the mobi-c implant, the surgeon noticed that the polyethylene mobile insert was displaced from the implant and sheared off.Thus creating the disc space to compress.X-rays and images were provided.The implant was replaced by acdf.No known patient impact were reported on post-revision.Additional information provided on february 8th 2019: the reporter don't know the reference and lot number of the implant.No additional information were received about the mobile insert part.The original surgery was performed by dr.King at rose medical about two years ago.The patient is not a smoker.No patient trauma or accident was reported.Additional information received on february 16th 2019: no update on the patient state of health.The issue was identified at the date of revision surgery.

• Brand Name: MOBI-C P&F US IMPLANT
• 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: 8338698
• MDR Text Key: 136116109
• Report Number: 3004788213-2019-00036
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NO INFORMATION
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR