MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

The product is not received yet.No examination was yet done 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.Conclusion is not available yet, investigation still in progress, the product.Not received yet.

Event Description

Mobi-c p&f us : disassembled.As reported : "with the implant on the inserter the surgeon noticed the superior endplate was very loose in the peek holder.It was noted by surgeon that the peel pieces seamed to be separating - causing endplates to not be secured.Surgeon, requested new implant to be opened." surgery was delayed 3 minutes.The patient wasn't affected at all.These events happened before surgeon attempted implantation.Additional information received by the reporter on may 14th appears to be inconsistent with the first description received as to when, in the surgery phase, the event occurred.Clarification was requested.Investigation still in progress.

Event Description

Mobi-c p&f us : the endplate is loose.With the implant on the inserter the surgeon noticed the superior endplate was very loose in the peek holder.It was noted by surgeon that the peel pieces seamed to be separating - causing endplates to not be secured.Surgeon, dr (b)(6), requested new implant to be opened.Update on november 19th 2018 : it seemed that the top endplate had most if not all of the visible movement.There was no disassembly as reported in the previous report.

Manufacturer Narrative

The event has been reported as a disassembly.From information provided and after review of the case with product range manager, this case is not a disassembly but a endplate seemed loose by the manufacturer.This event is confirmed as "not a complaint" because the endplate is held by the back so the loose is normal.Device not returned to the manufacturer.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Type of Device: CERVICAL DISK PROTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7577400
• MDR Text Key: 110446327
• Report Number: 3004788213-2018-00191
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: MB3355
• Device Lot Number: 5294263
• Other Device ID Number: (01)03662663000000(17)220601(1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1