MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C P&F US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.Product was not returned yet, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.

Event Description

Mobi-c p&f us : too loose on inserter.As reported by sales rep ((b)(6)), upon impaction 15x15x17 implant came apart.Replaced with a 15x15x6 implant which dr.Said was flimsy on inserter.Ultimately, chose to fuse.Current complaint is on too loose implant.The disassembly event is treated in separate complaint.

Manufacturer Narrative

Correction to: (common device name), (udi number), (patient code).The returned device was evaluated.There was no failure mode detected.The complaint is not confirmed.

Event Description

It was reported that during surgery, the mobi-c implant was loose on the peek cartridge holding it.As such, a different implant was used in its place.No surgical impact was reported.

• Brand Name: MOBI-C P&F US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8735429
• MDR Text Key: 149223661
• Report Number: 3004788213-2019-00199
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000079
• UDI-Public: 03662663000079
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3556
• Device Lot Number: 5321859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1