MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3376
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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.Reference report 3004788213-2021-00101.
Event or Problem Description
It was reported that a revision surgery was performed to address device migration found during a 6-week post-operation follow-up.Both mobi-c devices were removed and replaced by a fusion construct during the revision.This is report one of two for this event.
Additional Manufacturer Narrative
Device evaluation: the polyethylene inserts were not returned for analysis.The endplates of both devices had evidence of iatrogenic damage, and impingement damage.The backside surfaces of the endplates showed remnants of bone.X-rays were not provided, so the migration cannot be confirmed.The damage seen could have occurred during removal or during plate interaction after migration.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient, operational or traumatic factors.Dhr review : per dhr reviews, the parts were likely conforming when they 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
It was reported that a revision surgery was performed to address device migration found during a 6-week post-operation follow-up.Both mobi-c devices were removed and replaced by a fusion construct during the revision.This is report one of two for this event.

• Brand Name: IMPLANT MOBIC M ST 13X17 H6 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: 12439578
• Report Number: 3004788213-2021-00100
• Device Sequence Number: 17366441
• Product Code: MJO
• UDI-Device Identifier: 03662663000109
• UDI-Public: (01)03662663000109(17)250301(10)5361728
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/21/2022

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: 03/01/2025
• Device Catalogue Number: MB3376
• Device Lot Number: 5361728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• 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: 08/13/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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 Sex: Female