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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Disassembly (1168)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

The review of the inspection records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Waiting for product return.Not received yet.

Event Description

Mobi-c p&f us : disassembly.Surgeon was adjusted the prosthesis at c5-c6 while still attached to inserter and the superior endplate came off the inserter.Another implant was inserted.Patient condition is good, no harm for patient.No delay.Additional information received from (b)(6) on jan.05th 2018 : > surgical technique was followed.> soft tissue enabled direct implementation so surgeon attempted a slight angled approach, followed by axial rotation adjustment.> disc space was not distracted more than during insertion when surgeon would adjusted the implant.> it is not possible to get x-rays.Additional information received from (b)(6) on jan.09th 2018: > it was not a revision.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.The device was not returned to the manufacturer for examination.From information provided, based on the product history records, and the recurrence of this type of event for this implant, it is assessed that the event could be due to surgeon mishandling while repositioning the device.It points out that the surgeon probably did not follow the instructions mentioned in the surgical techniques and did not apply a new distraction before trying to reposition the device.As indicated in surgical techniques : 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.The investigation found no evidence to indicate device issue.

Event Description

Mobi-c p&f us : disassembly.

• Brand Name: MOBI-C IMPLANT 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: 7227024
• MDR Text Key: 98518075
• Report Number: 3004788213-2018-00021
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5293842
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1