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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

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.Device not yet received by manufacturer.

Event Description

Mobi-c p&f us: disassembled it was a cervical disc replacement.From description received, the mobi-c implant "detached from peek holder".Surgery was completed successfully with another device.No impact on patient.Delay 5 min.Attempts have been made to collect additional information and no further information has been provided yet.

Manufacturer Narrative

This medwatch is submitted to correct mistakes and to give more information that zimmer already had for the initial submission of this report on 06/apr/2018 but were forgotten (so no additional information received, only correction).This medwatch is also submitted to send the result of the investigation of this complaint.The product has not been returned despite the reporter's information.No evaluation of the product could be performed.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 information provided, based on the product history records, the review of the case during complaint meeting, the recurrence of this type of event, the root cause cannot be determined.The event could be due to loading issue of the implant on implant holder, disc space not enough distracted, implant not inserted in the correct axis.However, due to the lack of information received from the reporter, this hypothesis could not be validated.Root cause: unknown.The investigation found no evidence to indicate a device issue.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Device not returned to manufacturer.

Event Description

It was a cervical disc replacement.From description received, the mobi-c implant "detached from peek holder" during insertion (surgeon was not attempting to reposition, just drive it into the disc space).Surgery was completed successfully with another device.No impact on patient.Delay 2 min.The surgical technique was followed according to the reporter.

• 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
• MDR Report Key: 7401982
• MDR Text Key: 104527341
• Report Number: 3004788213-2018-00098
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5292321
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1