MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 15X19 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3595
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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
It was reported that a patient presented with heterotopic ossification.A revision surgery is scheduled to remove the device.
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 presented with heterotopic ossification at level c5/6.A revision surgery was performed to remove the device.During removal of the device, the poly part of the implant was damaged.They used a rongeur to remove it.Once it was removed, the surgeon continued to decompress and then fused using a cage and plate.
Additional Manufacturer Narrative
Corrections in d1 and d4: catalog number, lot number, and udi number.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 presented with heterotopic ossification at level c5/6.A revision surgery was performed to remove the device.During removal of the device, the poly part of the implant was damaged.They used a rongeur to remove it.Once it was removed, the surgeon continued to decompress and then fused using a cage and plate.
Event or Problem Description
It was reported that a patient presented with heterotopic ossification at level c5/6.A revision surgery was performed to remove the device.During removal of the device, the poly part of the implant was damaged.They used a rongeur to remove it.Once it was removed, the surgeon continued to decompress and then fused using a cage and plate.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation product was returned and evaluated.All three components had evidence of iatrogenic damage.The articulating surface of the polyethylene insert showed machining marks, burnishing, and multidirectional scratches.Overall the results of the stage i analysis are consistent with a device having a short implantation time and iatrogenic damage.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.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X19 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: 15789402
• Report Number: 3004788213-2022-00096
• Device Sequence Number: 5501676
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: (01)03662663000185(17)200501(10)5239911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2023

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: 05/01/2020
• Device Catalogue Number: MB3595
• Device Lot Number: 5239911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/29/2022; 01/30/2023; 04/17/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/21/2022; 02/27/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Male