MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3375
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 3004788213-2021-00100.
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 two of two for this event.
Additional Manufacturer Narrative
Additional information in h4 and h6: component, investigation type, findings, and conclusions.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 two of two for this event.

• Brand Name: IMPLANT MOBIC M ST 13X17 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: 12439570
• Report Number: 3004788213-2021-00101
• Device Sequence Number: 4892272
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)251101(10)5374388
• 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: 11/01/2025
• Device Catalogue Number: MB3375
• Device Lot Number: 5374388
• 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: 12/23/2020
• 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