MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.The review of tracebaility and devices history records is ongoing.Product was not returned yet, no evaluation could be performed.Investigation still in progress.Not returned to manufacturer yet.
Event or Problem Description
Mobi-c p&f us : disassembled during repositioning.As reported, the surgeon was implanting the implant (with distraction) and decided he needed to reposition the implant after it was only implanted 50% of the way.He opened the caspar retractor to the maximum.When the surgeon pulled his hand back to pull the implant out, and just like the other case the lower plate came loose from the peek cartridge.A new implant of the same size was opened and used to continue the surgery.No patient impact nor surgery delay were reported.Additional information was requested, investigation is ongoing.
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.
Event or Problem Description
It was reported that during surgery, the implant disassembled while halfway in the disc space when the surgeon went to adjust the position.Another implant was used to complete the procedure.There were no patient impacts reported.

• Brand Name: IMPLANT MOBIC M ST 15X17 H5 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: 8770998
• Report Number: 3004788213-2019-00209
• Device Sequence Number: 16516381
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: 03662663000154
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 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: 09/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5321865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 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
• Patient Age: 39 YR