MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3355
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intervertebral Disc Compression or Protrusion (4524); Joint Laxity (4526)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
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
A revision surgery was performed to remove a mobi-c device at c5/6 due to instability, listhesis, and myelopathy.The level was converted to a fusion.The patient's symptoms improved after the revision.The surgeon stated this was probably not device related.
Additional Manufacturer Narrative
Device evaluation: product was not returned, and photos/ x-rays were not provided.Device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
A revision surgery was performed to remove a mobi-c device at c5/6 due to instability, listhesis, and myelopathy.The level was converted to a fusion.The patient's symptoms improved after the revision.The surgeon stated this was probably not device related.

• Brand Name: IMPLANT MOBIC M ST 13X15 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: 12748721
• Report Number: 3004788213-2021-00139
• Device Sequence Number: 5658933
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)240101(10)5331132
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: MB3355
• Device Lot Number: 5331132
• Was Device Available for Evaluation?: No
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: 70 YR
• Patient Sex: Female
• Patient Race: White