MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/21/2017

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 discarded by hospital.

Event Description

Mobi-c pf us disassembled.Surgeon performed discectomy in c6-c7 and trialed to determine appropriate size implant.Scrub tech loaded mobi-c onto inserter, which was verified by (b)(6), and passed implant/inserter to surgeon.Dr.(b)(6) put the implant into the open disc space and used a mallet to advance the implant.After the first mallet strike to advance the implant, he indicated the top endplate dis-engaged from the peek cartridge.(b)(6) asked him to remove the instrument/implant, so (b)(6) could visualize.(b)(6) verified that the plate had indeed dis-engaged and asked him to remove the upper endplate and they would open another mobi-c implant and try again.This time, everything was successful.Disassembled product discarded by hospital.Patient has recovered and is doing well.The patient was not affected by the issue.

Event Description

Mobi-c pf us disassembly.Additional information was recieved on the 10th of october 2017 stating that the patient has recovered and is doing well, he was not affected by the issue.The anatomy of the patient was not related to the issue.The disc space was under distraction and the initial placement of the implant was verified by the c-arm but with the first mallet impact the implant dis-engaged.No rotational movement was observed by the c-arm.No x-rays were provided.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Date of report ; event; 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.Attempts were made to collect additional information.According to the reporter there was distraction applied prior implant insertion , no rotational move was applied.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 during device insertion probably due to a lack of distraction.However, based on the information received from the reporter this hypothesis could not be validated, the cause for the event cannot be determined.The cause for the device disassembly remain undetermined because of the lack of information received from the reporter.The investigation found no evidence to indicate a device issue.If additional information was received that allow to draw a conclusion for this case , another report will be sent.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.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.Attempts were made to collect additional information.According to the reporter there was distraction applied prior implant insertion , no rotational move was applied.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 during device insertion probably due to a lack of distraction.However, based on the information received from the reporter this hypothesis could not be validated, the cause for the event cannot be determined.The cause for the device disassembly remain undetermined because of the lack of information received from the reporter.The investigation found no evidence to indicate a device issue.If additional information was received that allow to draw a conclusion for this case , another report will be sent.

Event Description

Mobi-c pf us disassembled additional information was recieved on the (b)(6) 2017 stating that the patient has recovered and is doing well, he was not affected by the issue.The anatomy of the patient was not related to the issue.The disc space was under distraction and the initial placement of the implant was verified by the c-arm but with the first mallet impact the implant dis-engaged.No rotational movement was observed by the c-arm.No x-rays were provided.

• Brand Name: MOBI-C IMPLANT 15X17 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: 6954450
• MDR Text Key: 89486700
• Report Number: 3004788213-2017-00151
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5285919
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR