MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Mobi-c p&f us : disassembly surgeon executed a 2 level mobi-c.After successfully implanting lower level, surgeon implanting proximal level.Upon impaction, device loosened from peek cartridge & was replaced with implant from the same size.Loosen device discarded.No harm to patient.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.From additional information received, surgeon encountered resistance while inserting prosthesis and may have inserted it with a slight angle.Surgeon tried to reorient the trajectory.From this description, probable cause identified during complaint meeting of (b)(6) 2017 is user error.

• Brand Name: MOBI-C IMPLANT 15X17 H6 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: 6972750
• MDR Text Key: 90077981
• Report Number: 3004788213-2017-00159
• 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: 10/24/2017

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: 05/01/2020
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: 5249900
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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