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

Model Number N/A

Device Problems Material Separation (1562); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

Device not yet received by manufacturer.

Event Description

Mobi-c p&f us : jammed.Surgeon had difficulty while trying to remove jaws.Implant fell apart and actually came out with the retaining clip.Another new mobi-c implant was implanted.Additional information provided indicate that "there had been a slight resistance when lifting out the peek implant clamp".Then surgeon should have rotate the convex jaw first (as it is the less bulky) by 90° caudal & pull it back along the disc axis (described in the surgical technique).The probable cause is user error.Product is returned (not received yet) for further investigation distributor will provide a reminder to educate user.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation od this complaint.Product was received and visual examination was performed.Product was found 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.From information provided, based on the product history records, the examination of the returned product and the recurrence of this type of event for this implant, the likely cause of the event is user error while removing peek jaws from the implant.It points out that the surgeon did not follow surgical technique.Indeed, the surgeon encountered resistance while using the clamp to remove peek parts.He should have rotated the convex jaw first (as it is the less bulky) by 90° caudal & pull it back along the disc axis (described in the surgical technique).As described in surgical technique, "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." the investigation found no evidence to indicate device issue.Root cause : instruction was not followed.

Event Description

Mobi-c p&f us : jammed.

• 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: 6841209
• MDR Text Key: 85636276
• Report Number: 3004788213-2017-00067
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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: 5283979
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR