MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C P&F IMPLANT 15X17 H5; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB2575

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Product code: this device is not cleared within the us, but is similar to those cleared under mjo.This device is not cleared within the us, but is similar to those cleared under (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 it was difficult to place the implant in the disc space and it broke on the inserter.There was an undisclosed delay and harm to the patient with no further information provided.

Event Description

It was reported it was difficult to place the implant in the disc space and it broke on the inserter.There was an undisclosed delay and harm to the patient with no further information provided.

Manufacturer Narrative

Added information to h6: component codes, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information summary: the complaint is unrefuted for the failure of implant broke.The product was not returned and no photos were provide.Medical records were not provided for review.Potential cause since the product was not returned, root cause can't be established.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.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: MOBI-C P&F IMPLANT 15X17 H5
• 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
• MDR Report Key: 10864407
• MDR Text Key: 217063493
• Report Number: 3004788213-2020-00199
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663018588
• UDI-Public: (01)03662663018588(17)231001
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: MB2575
• Device Lot Number: L082285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other