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	Disconnection (1171); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
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.Not returned to manufacturer yet.
Event or Problem Description
Mobi-c p&f us : disassembled during peek removal.The patient was undergoing a c6-7 disc arthroplasty using mobi-c implant according to the surgical technique.After insertion of the implant, the surgeon used the extraction forcep mb9075r to attempt to remove the peek cartridge per technique.He squeezed the forceps in the side notches, lifted to pull out the cartridge and it was not released.He tried squeezing the cartridge further and lifted but no release and the cartridge remained on the implant and was pulled out.It was difficult to remove the forceps from the removed implant.The surgeon proceeded to implant a replacement mobi c of the same sizing without incident.The surgeon has asked that the patient not be billed for the first implant.No delay greater than 30 minutes was reported.Additional information was requested.Investigation still in progress.
Event or Problem Description
It was reported that during the peek cartridge removal, the implant would not disconnect from the cartridge.The implant was removed from the disc space and the procedure was completed with another mobi-c implant of the same size.There were no patient impacts.
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 dhr did not find any issues which would have contributed to this event.

• 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: 8788456
• Report Number: 3004788213-2019-00216
• Device Sequence Number: 2638644
• Product Code: MJO
• UDI-Device Identifier: 03662663000161
• UDI-Public: 03662663000161
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/12/2020

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: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: 5314953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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
• Patient Age: 50 YR