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

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Products are still implanted.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Review of provided x-rays shows the cervical spine appears rather unbalanced.There is no lordosis.All levels are discopathic.Like the discs, the vertebral bodies have also lost their height.Finally, the 2 prostheses do not cover the vertebral plates correctly.From the information provided, the product history records, the review of the case with the product manager, the recurrence of this type of event for this product and after review of x-rays, the investigation found no evidence to indicate a device related issue.The root cause is related to an off-label as spine anatomy of patient is a contraindication for mobi-c implantation.As indicated into mobi-c us surgical technique as contraindication : "compromised vertebral bodies at the index level due to previous trauma to the cervical spine or to significant cervical anatomical deformity or disease (e.G., ankylosing spondylitis, rheumatoid arthritis)." product still implanted.
Event or Problem Description
Mobi-c p&f us : position incorrect post-op.It was reported that sales rep.Received a text message from surgeon with images of mobi-c implant that appears to displace with flexion.He said patient had no clinical issues to date.Asked if he would get some corporate feedback on images.Patient is asymptomatic.

• Brand Name: MOBI-C IMPLANT 15X17 H5 US
• Common Device Name: 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: 8707151
• Report Number: 3004788213-2019-00173
• Device Sequence Number: 1992366
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)221101(10)5302944
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5302944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1