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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2021
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 that a patient had an implantation surgery in 2017 that routine x-rays showed had migrated anteriorly.The patient had no issues with this implant for over four years.The patient elected to have removal of the implant for conversion to fusion.During removal, the surgeon commented that the poly core was proud.The surgeon removed the core with a needle holder and found that it was broken.Several tiny pieces of the core were also removed, then the endplates were removed.The removal and conversion to fusion went as planned.
Event or Problem Description
It was reported that a patient had an implantation surgery in 2017 that routine x-rays showed had migrated anteriorly.The patient had no issues with this implant for over four years.The patient elected to have removal of the implant for conversion to fusion.During removal, the surgeon commented that the poly core was proud.The surgeon removed the core with a needle holder and found that it was broken.Several tiny pieces of the core were also removed, then the endplates were removed.The removal and conversion to fusion went as planned.
Additional Manufacturer Narrative
Corrections in d1; d4: catalog number, lot number, and udi number; and h3.Additional information in d4: expiration date , h4, and h6: component, investigation type, findings, and conclusions.Part evaluation: the returned part was evaluated and the mobile core was found damaged as described by the reporter.Review of the x-ray showed the core had migrated.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient factors, implanting next to prior fusions, or other operational factors.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.

• 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: 11924379
• Report Number: 3004788213-2021-00059
• Device Sequence Number: 3685328
• Product Code: MJO
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/07/2021

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: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5283983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• 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: 05/05/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2017
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female