MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X19 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report.The review of the device history records and traceability did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.It was indicated that the product was scrapped.Therefore, no product evaluation could be performed.Additional information was required and still pending.Investigation is still in progress.Conclusion is not yet available.Product discarded.
Event or Problem Description
Mobi-c p&f us: 2 implants disassembled during insertion.It was reported by sales rep.That during a mobi-c surgery: surgeon did everything in accordance with the technique guide.The tech followed technique guide as well when placing implants on inserter.No touch was followed.Disc space was distracted.During the process of inserting implant into disc space c6/c7 the inferior plate of the implant dislodged from implant while still on inserter.This happened to both implants.Followed the same exact procedure for third implant and it worked perfectly.No harm to patient.There was no patient impact or surgery complication.Additional informations received on june 10th: the patient current health is good, the situation described did not have an affect on patient health.The depth stop was set at zero and technique guide steps were followed according to the reporter, the disc space was under distraction when event occured; surgeon may have had some resistance initially but it did not seem like anything abnormal.No mobi-c level was used during surgery.No rotational move was performed during insertion.Investigation is in progress.
Additional Manufacturer Narrative
Correction: a1, a2, b5, b6, d1, d2 (common device name), e1, e2, e3, g3, h1, h3, h6 (device code) additional info: b7, g5 (pma/510k), h6 (methods, 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.
Event or Problem Description
It was reported that the inferior endplates of two mobi-c implants dislodged from the implant during insertion.The procedure was completed with a third mobi-c implant.There was no patient impact reported.This is report one of two.

• Brand Name: IMPLANT MOBIC M ST 15X19 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: 8690651
• Report Number: 3004788213-2019-00159
• Device Sequence Number: 2353908
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: (01)03662663000185(17)221101(10)5301059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5301059
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 06/12/2019
• 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: 52 YR