MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer.It was discarded by the hospital.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.Additional information were requested to the reporter about the event.Conclusion of this case is not yet available , investigation still in progress.Device not returned to manufacturer.

Event Description

Description received from reporter : the implant expulsed while trying to extract peek cartridge.Not surgeon error (implant pulled out).No impact on patient was reported.No surgical complication occured.A delay of 15 min in the surgery was notified.

Manufacturer Narrative

Based on the product history records, the review of the case, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.Requests for additional information and product return did not receive a response.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: unknown with hypothesis of mishandling during peek cartidge removal based on the description and the device history review ( not following the step 14 of the surgical techniques).Howver due to the lack of provided data this assumption cannot be validated.If additional informations were received another report will be sent.

Event Description

Mobi-c p&f us : disassembly description received from reporter : the implant expulsed while trying to extract peek cartridge.Not surgeon error (implant pulled out).No impact on patient was reported.No surgical complication occured.A delay of 15 min in the surgery was notified.Severals attempts were made to collect additional information.No addi received.The device was not returned for examination.

• Brand Name: MOBI-C IMPLANT 13X15 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: 7443582
• MDR Text Key: 105937709
• Report Number: 3004788213-2018-00114
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5293824
• Other Device ID Number: 01036626630000621722060110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1