MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Break (1069); Disconnection (1171); Misassembled (1398); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

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.The product evaluation has not been performed yet, as the product has not been returned for the moment.Upon receipt of the product, the product evaluation will be performed.Attempt has been made to the reporter to collect additional information concerning the reported event.Investigation is still in progress.Conclusion not yet available.Device not returned yet.

Event Description

Mobi-c p&f us : rotated and then disassembled.From information provided by reporter: it was a 2 level mobi-c case.Surgeon successfully placed 1st level implant following surgical technique.Surgeon followed proper surgical technique for placing the 2nd level implant, utilizing inserter and level instruments to ensure proper alignment of implant (both sales reps in room watched to confirm that level was straight going in).When taking confirmation shot, implant appeared very rotated.Patient was distracted, and implant fell apart while being removed.It was determined to open new implant of the same size.According to the reporter : level instrument / surgical technique determined to be the problem because didn¿t account for patient¿s rotated anatomy.No harm to the patient.The surgery was delayed between 5 and 10 minutes.Attempt has been made to the reporter to collect additional information concerning this reported event.

Manufacturer Narrative

The product was not returned to the manufacturer.Therefore, no product evaluation could be performed.From the information provided based on the complaint report , the product history records and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, as reported, the surgeon tried to reposition the implant.It is clearly indicated in the surgical technique to check implant assembly to peek cartridge before reinsertion if reinsertion is needed (step 11: device insertion).However, regarding the lack of information provided and without the product return and evaluation, this hypothesis cannot be validated.If additional information is received that allows to draw a conclusion, another report will be sent.

Event Description

Mobi-c p&f us : disassembly.It was a 2 level mobi-c case.Surgeon successfully placed 1st level implant following surgical technique.Surgeon followed proper surgical technique for placing the 2nd level implant, utilizing inserter and level instruments to ensure proper alignment of implant (both sales reps in room watched to confirm that level was straight going in).When taking confirmation shot, implant appeared very rotated.Patient was distracted, and implant fell apart while being removed.It was determined to open new implant of the same size.There was no report about a patient impact or surgery complication.Another report was sent related to instruments difficulty of use (registered internally in the complaint (b)(4)).

Event Description

Mobi-c p&f us : rotated and then disassembled.Additional information received on february 21st 2019: the reporter does not know the patient's current state of health but the rotated implant was removed and a new one was placed appropriately, so this should not have any affect on the patient's health.No pre-, per- and post-op x-ray images are available but the two discs implanted and remaining in the patient were correctly positioned.The inserter and level used for the implantation of the first level were used for the implantation of the second level.The first implant went in straight using the inserter with level, but the second implant went in rotated using the same surgical technique and the same instrumentation.The surgeon noticed that the implant was rotated when the surgeon takes a shot once the implant has been inserted with depth stop set at 0.The implant was nearly completely inserted at this point, without ability to correct the rotation with the additional 1-3 mm remaining for final insertion using depth stop adjustments.The reporter mentioned a dificulty during the use of the instruments due to the patient rotated anatomy on the coronal plate.According to the reporter, the surgical technique was followed, during implant assembly in the inserter.

Manufacturer Narrative

This medwatch is submitted to send the medwatch follow-up report of the investigation following the additional information received.B4, b5, g1-2, g4, g7, h2, h6 and h10 were updated.Event update is showed in b5 section.The product evaluation has not been performed yet, as the product has not been returned.Upon receipt of the product, an evaluation will be performed.Investigation is still in progress.Conclusion is not yet available.

• Brand Name: MOBI-C IMPLANT 15X15 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: 8356981
• MDR Text Key: 136730611
• Report Number: 3004788213-2019-00041
• 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,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5293834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR