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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Mobi-c p&f us : disassembly.When user tried to remove the peek jaws, it caused a disassembly of the implant a second implant was opened, but when inserter was removed, it caused a rotation of the implant.Both events are related to a user error.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Date of report ; event; mfr site; report source; pma/510k ; if follow-up, what type were updated.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Severals attempts were made to collect information on device disassembly.The only information provided it that the prothesis rotated upon inserter removal.Regarding the lack of information , the exact root cause remain undetermined.Investigation found no evidence on a device issue.If additional information was received that allow to draw a conclusion.Another report will be sent.

Event Description

Mobi-c p&f us : disassembly.When user tried to remove the peek jaws, it caused a disassembly of the implant.A second implant was opened, but when inserter was removed it caused a rotation of the implant.Both events are related to a user error.Both cases happened in the same level c4-c5.No patient impact.This report is about the second implant disassembly.

• 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
• MDR Report Key: 6827058
• MDR Text Key: 84260850
• Report Number: 3004788213-2017-00061
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: 12/01/2020
• Device Model Number: N/A
• Device Catalogue Number: MB3375
• Device Lot Number: 5258411
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1