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

Model Number	N/A
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Device Handling Problem (3265)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004788213-2019-00199
• Device Sequence Number: 2271451
• Product Code: MJO
• UDI-Device Identifier: 03662663000079
• UDI-Public: 03662663000079
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 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
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/19/2020
• 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