MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X17 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Mobi-c p&f us : size issue.One implant was implanted and removed because surgeon decided he would prefer deeper implant.Surgeon initially like trial with 13mm depth but decided that 15mm depth would be more appropriate after seeing implant placed.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Following surgical technique, surgeon should have chosen a size that achieves complete a/p coverage.Cause identified in complaint meeting is user error.

• Brand Name: MOBI-C IMPLANT 13X17 H5 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: loic richard ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3325823263
• MDR Report Key: 6989686
• MDR Text Key: 90628137
• Report Number: 3004788213-2017-00166
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2017

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: 02/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3375
• Device Lot Number: 5265936
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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 Age: 42 YR