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 Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

The review of traceability and review of device history records did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event.According to surgical technique, "during and after insertion, avoid lateral and rotational movements of the implant-to-peek cartridge assembly." and " if necessary to correct a rotated device or for lateral implant adjustments, distraction of the disc space is required to prevent implant-to-peek cartridge disassembly in situ." regarding description, investigation, review of traceability and dhr, probable cause is related to user error while repositioning the prosthesis.Implant not yet received by manufacturer.

Event Description

Mobi-c p and f us : disassembly.Mobi-c was implanted into disc space.And when surgeon was in the process of repositioning the implant, peek cartridge disengaged from the mobi-c implant and the 3 components of the prosthesis was loosened.Surgery was completed successfully with same size implant.No impact on patient.Reporter don't have additional information (on surgical steps) on this case.

Event Description

Mobi-c p&f us : disassembly according to the complaint report a mobi-c was implanted into disc space.And when surgeon was in the process of repositioning the implant, peek cartridge disengaged from the mobi-c implant and the 3 components of the prosthesis was loosened.Surgery was completed successfully with same size implant.No impact on patient attempts were made to the reporter who covered the event , he don't have any additional information (on surgical steps) for this case.Device was not returned for examination.

Manufacturer Narrative

Although it was mentioned that the device will be sent back for examination.The device was not returned to the manufacturer.The review of the device history records and traceability show no evidence on a device issue that may have impacted this event.Attempts were made to collect informations on the surgical steps followed that may explain this case.The reporter didn't provide any update.Based on the description , the disassembly occured when the surgeon tried to reposition the implant.Indeed, as mentioned in the surgical technique : during and after insertion, avoid lateral and rotational movements of the implant-to-peek cartridge assembly.Therefore , after the device history record review and the recurrence of this kind of event , the probable root cause may be related to mishandling during implant repositioning.However, regrading the lack of information and the absence of device examination , this assumption cannot be validated.Investigation found no evidence on a device issue.Root cause : undetermined with user error hypothesis.If additional informations were received , another report will be sent.

• 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: 7163637
• MDR Text Key: 96347393
• Report Number: 3004788213-2018-00002
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5284626
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 31 YR