MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT M"STANDARD" 13X17 H6; MOBI-C CERVICAL DISC PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problems Ossification (1428); Pain (1994)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Device product code: similar to mjo.Pma/510(k) number: similar to p110009.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 the patient experienced pain several months post-op after he raised his arm.A revision surgery was performed to remove the implant.X-rays clearly showed a rotation of a prosthesis tray with a dislocated nucleus.It is unclear when the inferior plate was found to have integrated with the bone, but the superior plate did not and the mobile core was broken.This occurred at level c6-7.

Event Description

It was reported that the patient experienced pain several months post-op after he raised his arm.A revision surgery was performed to remove the implant.X-rays clearly showed a rotation of a prosthesis tray with a dislocated nucleus.It is unclear when the inferior plate was found to have integrated with the bone, but the superior plate did not and the mobile core was broken.This occurred at level c6-7.

Manufacturer Narrative

Product evaluation: the device was not returned and no photos or x-rays/imaging were provided so an evaluation was unable to be performed.Dhr review and applicable actions: the dhrs for the plates and mobile core were reviewed.All dimensions inspected were found conforming to the drawing specifications.All material was found to meet their applicable regulation specifications, including mechanical and strength requirements.There are no indications that there were any manufacturing or material issues that would have contributed to this event.Device usage: this device is used for treatment.Ifu review: the ifu was reviewed and was found to contain warnings and other information related to pain, device migration, and device breakage.Potential cause: the potential cause cannot be identified since there is insufficient information available.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.

• Brand Name: MOBI-C IMPLANT M"STANDARD" 13X17 H6
• 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: 12044289
• MDR Text Key: 257703419
• Report Number: 3004788213-2021-00061
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663018395
• UDI-Public: (01)03662663018395(17)220601(10)L081740
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB2376
• Device Lot Number: L081740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 41 YR