MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Fracture (1260)
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 is not available and it will not be returned, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.Product not available.
Event or Problem Description
Mobi-c p&f us : disassembled before insertion.As reported by sales rep, : implant fell apart upon opening, before insertion.No other information was provided.No patient impact or surgery complication were reported.Additional information was requested.Investigation still in progress.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that the peek cartridge was broken when the package was opened.The implant never touched the patient and a second implant was opened and used to complete the surgery.No patient impacts were reported.
Event or Problem Description
It was reported that the mobi-c peek cartridge was broken when the package was opened.The implant never touched the patient and a second implant was opened and used to complete the surgery.No patient impacts were reported.
Additional Manufacturer Narrative
Additional information in b5, d4 (udi number), e4, h4, and h6: method, results, and conclusions codes.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: MOBI-C IMPLANT 15X17 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8801479
• Report Number: 3004788213-2019-00231
• Device Sequence Number: 457555
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: 03662663000154
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,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: 10/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5327122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 02/14/2020; 06/24/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 03/13/2020; 08/20/2020
• 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