MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	Partial Blockage (1065); Device Dislodged or Dislocated (2923); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report.The review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Product was not returned at this time.Attempts have been made to collect additional information concerning the reported event, without responses yet.The investigation still in progress.
Event or Problem Description
Mobi-c p&f us : position incorrect, implant replaced.It was reported by sales representative that during a mobi-c surgery, surgeon inserted a mobi implant and upon fluoro shot saw that something was off as the inferior endplate was locked at an odd angle.The implant was removed and another implant was opened.The case went fine.After the case, sales representative inspected the implant and the mobi inferior endplate was locked in to the peek cartridge and wouldn¿t move.Additional information was requested.
Additional Manufacturer Narrative
The mobi-c implant was returned.The inferior endplate was found to be locked at an odd angle as reported.Evaluation of the returned mobi-c implant confirmed that the implant had no visual or functional damage.Therefore, a possible cause is over threading of the knob while initially loading the implant.A review of the manufacturing records did not identify any issues which would have contributed with this event.
Event or Problem Description
It was reported that the inferior endplate of the implant was noted to be locked at an odd angle in the disc space during surgery.The implant was removed and another implant of the same size was used to complete the procedure.No patient impact was reported.

• Brand Name: IMPLANT MOBIC M ST 15X15 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: 8626891
• Report Number: 3004788213-2019-00149
• Device Sequence Number: 2259691
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)230101(10)5320068
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5320068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 04/24/2020
• 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