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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) number: (b)(4).Without a product return, no product evaluation is able to be conducted.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 Description

It was reported that during a 3 month post op visit from a level 2 cervical disc replacement the physician was made aware of abnormal imaging showing some slippage of the device at the c5-6 level.The patient is asymptomatic and the physician is not currently considering revision surgery.

Manufacturer Narrative

Information added to h6: type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information.Summary the complaint is confirmed for one (1) of one (1) unreturned mobi-c implant (pn: mb3595) for the failure of implant migration post-op.Despite the product was not returned for evaluation, the failure of implant migration can be confirmed via the provided x-rays.Medical records were not provided for review.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the implant was being implanted.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that during a 3 month post op visit from a level 2 cervical disc replacement the physician was made aware of abnormal imaging showing some slippage of the device at the c5-6 level.The patient is asymptomatic and the physician is not currently considering revision surgery.

• Brand Name: IMPLANT MOBIC M ST 15X19 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, n/a 10300 ; FR 10300
• MDR Report Key: 11401487
• MDR Text Key: 234749649
• Report Number: 3004788213-2021-00019
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5302954 OR 5301060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 44 YR