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

Catalog Number	MB3555
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported the patient had persistent neck pain and the surgeon elected to remove the mobi-c implant at c6/7 and convert it to an acdf.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported the patient had persistent neck pain and the surgeon elected to remove the mobi-c implant at c6/7 and convert it to an acdf.
Event or Problem Description
It was reported the patient had persistent neck pain and the surgeon elected to remove the mobi-c implant at c6/7 and convert it to an acdf.
Additional Manufacturer Narrative
Device evaluation: per the device analysis: "the articulating surface of the polyethylene insert showed machining marks and multidirectional scratches consistent with minimal wear.Overall the results of the analysis are consistent with a device having short implantation time.Additional analysis was conducted to assess the condition of the polyethylene insert.This analysis found a low oxidation level of the insert (oi < 1) and mechanical properties consistent with this level of oxidation." the technical evaluation does not provide any indication that the product caused the patient pain.Nor does it show any particular device problem.The complaint is unrefuted.Potential cause: root cause was unable to be determined.This event could possibly be attributed to operational or patient factors.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: IMPLANT MOBIC M ST 15X15 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, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13003367
• Report Number: 3004788213-2021-00165
• Device Sequence Number: 4829545
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062(17)240601(10)5343111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: MB3555
• Device Lot Number: 5343111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 126 KG