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

Model Number N/A

Device Problems Difficult to Remove (1528); Sticking (1597); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

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.Product is not returned yet.No examination was performed.Investigation is in progress.Conclusion is not yet available.Device not received yet by manufacturer.

Event Description

Mobi-c p&f us : jaws stuck & implant disassembly from information reported, the mobi-c implant was implanted and inserter was "properly unscrewed and disengaged".Surgeon proceeded to remove the two peek parts : "right side came off with no hesitation, but the left side appeared to be stuck".Eventually, both peek and disc were removed.Surgery was completed successfully with another device from the same size.No impact on patient.No surgery delay was reported.Update provided on april 10th 2018 shows that according to reporter, disc space was well distracted, surgical technique was followed while loading the implant on implant holder.Also, that the surgeon minimal resistance while inserting prothesis.The information provided on the peek removal allowed to conclude that the jammed peek part must have been against the uncus and couldn't detached.Product will be returned and evaluated.Investigation is in progress.

Event Description

Mobi-c p&f us : jaws stuck & implant disassembly.From information reported, the mobi-c implant was implanted at c5-c6 and inserter was "properly unscrewed and disengaged".Surgeon then proceeded to remove the two peek parts : "right side came off with no hesitation, but the left side appeared to be stuck".Eventually, both peek and disc were removed.Surgery was completed successfully with another device from the same size.No impact on patient.Delay 10 min (for replacement of the implant).Update provided on april 10th 2018 shows that according to reporter: surgical technique was followed while loading the implant on implant holder.Disc space was well distracted, the surgeon encountered minimal resistance while inserting prothesis.-o not recall if there was an angle or rotational move performed during insertion.No clear information about peek holder removal process (especially concerning the 90° caudal step used to ease the removal).But the convex jaw was removed first.

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 24/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 traceability and 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, 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 a wrong maneuver during removal of peek cartridge (maybe the jammed peek part was against the uncus and couldn't detached).As mentioned in the surgical techniques: " if the peek cartridge is difficult to extract, rotate one side of the cartridge 90° caudal, then remove with forceps.Repeat on the remaining side ".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.

• 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: 7453517
• MDR Text Key: 106255330
• Report Number: 3004788213-2018-00117
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5295559
• Other Device ID Number: (01)03662663000000(17)220701(1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 52 YR