MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Disassembly (1168); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

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.From information provided, based on the product history records, and the recurrence of this type of event for this implant, it is assessed that the event could be due to mishandling when removing the cartridges.It points out that the surgeon probably did not follow the instructions mentioned in the surgical techniques.However, the description received did not allow to understand perfectly if the surgical steps were followed or not.This hypothesis could not be validated.The cause for the cartridge issue and the device disassembly is unknown.The description received did not allow to understand perfectly if the surgical steps were followed or not.The investigation found no evidence to indicate a device issue.Investigation found no evidence on a product issue.Device not returned to manufacturer.

Event Description

Mobi-c p and f us : implant difficult to release and implant disassembly from information provided, surgeon implanted mobi-c prosthesis attached to cartridge and was satisfised with placement.He "moved to next step using forcep to remove peek cartridge but peek cartridge would not separate from implant.Agent then instructed surgeon to remove the peek cartridge individually with a ¿pick up,¿ instrument.The peek then released and was removed from the implant".Upon follow up x-rays it was determined implant had moved from original positioning.Surgeon thought was that "something was off with this implant" and removed it.No delay of more than 30 min has been reported.The surgery was completed successfully with another implant of the same size.No impact on the patient.Additional information was requested.But reporter cannot remember details about the case.

• Brand Name: MOBI-C IMPLANT 15X15 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7557338
• MDR Text Key: 109673352
• Report Number: 3004788213-2018-00182
• 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: 05/31/2018

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5281384
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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: 28 YR