MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Mobi-c p&f us : revision due to device loosening.Device was removed to fusion.Patient condition is good after surgery.Three requests for additional information.Still waiting for an answer.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.After several attempts to obtain information, it was not possible to get the reference and lot number of the product.It was not possible to perform the review of the device history records.Based on the review of the case, the recurrence of this type of event for this implant, the root cause of the event cannot be determined.Requests for additional information and product return did not receive any response.It could not even be possible to make hypothesis about the root cause of the event.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: unknown.

• Brand Name: MOBI-C IMPLANT US
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; 5, rue de berlin; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6899905
• MDR Text Key: 87591365
• Report Number: 3004788213-2017-00108
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR