MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H6 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	Device Handling Problem (3265); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
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.Additional information was requested.Investigation still in progress.
Event or Problem Description
Mobi-c p&f us : implant too loose on inserter.As reported by the sales representative, surgeon felt implant was very loose and afraid it wouldn't stay together upon implantation.Surgery was completed with another device of same size.No delay was reported.Additional information was requested.Investigation ongoing.
Event or Problem Description
Mobi-c p&f us : implant too loose on inserter.As reported by the sales representative, surgeon felt implant was very loose and afraid it wouldn't stay together upon implantation.Surgery was completed with another device of same size.No delay was reported.Additional information was received on july 5th 2019: current health of patient is good.Depth stop was at 0 initially.Care was taken to tighten only until contact on peek cartridge.No difference in technique between first and second implant.Surgical technique is followed.Investigation still in progress.
Additional Manufacturer Narrative
This medwatch is submitted to send the result of the investigation of this complaint.Additional information was received.Product return was requested.Investigation still in progress.
Additional Manufacturer Narrative
The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the production records does not indicate that a manufacturing issue contributed to this issue.If further information is received, a supplemental report will be sent.
Event or Problem Description
It was reported that during surgery, the surgeon felt the implant's connection to the inserter was too loose.Another implant of the same size was used in its place and no patient or surgical impact was reported.

• Brand Name: IMPLANT MOBIC M ST 15X17 H6 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: 8735451
• Report Number: 3004788213-2019-00200
• Device Sequence Number: 2639047
• Product Code: MJO
• UDI-Device Identifier: 03662663000161
• UDI-Public: 03662663000161
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2020

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: 06/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: 5316642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/05/2019; 03/31/2020
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/29/2019; 04/30/2020
• 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