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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524)

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

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

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.Based on the product history records and the recurrence of this type of event for this implant, the investigation found no evidence to indicate a device issue.The information initially provided ("the peek cartridge detached from the implant partially") & the event update provided after additional request attempts have been made ("the extraction forceps could not release the peek cartridge from the implant") are not consistent.From another information provided ("mobi-c would not advance or rotate to correct positioning"), the likely cause for the event is a mishandling when trying to reposition the device.It points out that the surgeon probably did not follow the instructions mentioned in the surgical techniques as indicated in st : "during and after insertion, avoid lateral and rotational movements of the implant-to-peek cartridge assembly." the investigation found no evidence to indicate device issue.Root cause : user error (instruction was not followed).Device not returned to manufacturer.

Event Description

Mobi-c p&f us : disassembly.From information provided, while mobi-c device was implanted, "peek cartridge detached from the implant partially, mobi-c would not advance or rotate to correct positioning." no delay of more than 30 min has been reported.The surgery was completed successfully with another implant of the same size.No impact on the patient.Additional information was received on may, 1st 2018 : according to reporter, the surgical technique was followed while loading implant on inserter.Reporter doesn't remember exactly the distraction amount, but he always requests the disc space to be distracted half way or less so there is slight resistance when advancing implant & using the mallet.He can't remember if a rotational movement was done while impacting device.There was no resistance problems, "just that the extraction forceps could not release the peek cartridge from the implant".Attempts have been made but no other information wasn't provided.

• 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7553622
• MDR Text Key: 109582197
• Report Number: 3004788213-2018-00174
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5265457
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 42 YR