MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3575

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/08/2022

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed for a mobi-c device because radicular pain was not resolved post-operatively.More extensive posterior decompression was required.The mobi-c was replaced with an acdf construct.

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 Description

It was reported that a revision surgery was performed for a mobi-c device because radicular pain was not resolved post-operatively.More extensive posterior decompression was required.The mobi-c was replaced with an acdf construct.

Manufacturer Narrative

Device evaluation per the exponent report: "the articulating surface of the polyethylene insert showed machining marks and multidirectional scratches consistent with minimal wear.Cutout deformation on polyethylene insert was observed.Overall the results of the stage i analysis are consistent with a device having impingement and a short implantation time." based on what can be seen on the device, the failure of removed due to persistent post-op pain cannot be confirmed.The complaint is unrefuted.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 review, the part was likely conforming when it left zimvie 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 15X17 H5 US
• Type of Device: 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: 14463075
• MDR Text Key: 294776994
• Report Number: 3004788213-2022-00039
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: MB3575
• Device Lot Number: 5332657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male