MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Device Problem Mechanical Problem (1384)

Patient Problems Neck Pain (2433); No Code Available (3191)

Event Type  Injury  

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 Description

It was reported that a revision surgery was performed to remove an implant secondary to the patient presenting post operatively with neck pain and the disc being reported to be locked in place.The level was fused during the revision.

Manufacturer Narrative

Methods, results, and conclusion codes.The product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Without the returned product, the event is non-verifiable.

Event Description

It was reported that a revision surgery was performed to remove an implant secondary to the patient presenting post operatively with neck pain and the disc being reported to be locked in place.The level was fused during the revision.

• Brand Name: MOBI-C IMPLANT, UNKNOWN SIZE
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 8962109
• MDR Text Key: 156584400
• Report Number: 3004788213-2019-00281
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention