MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H6 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report.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.Investigation still in progress.No conclusion available yet.Device not returned yet.

Event Description

Mobi-c p&f us: implant looks loose before implantation.From information reported by the reporter: the implant was opened from packaging and loaded onto the inserter.The implant and inserter were handed to the surgeon who commented that the implant look loose and like it was going to fall apart.Surgeon asked for a brand new implant and didn¿t want to risk implanting what he thought was a faulty implant.We complied with the surgeon request and loaded a new implant no issue on loading or implanting the new implant.New implant was the same size and lot #.No harm to the patient.Update on december (b)(6) 2018, according to the reporter: no delay more than 30 minutes on surgery.Implant properly loaded on the inserter.No difference in surgical steps between the first and the second implant.

Manufacturer Narrative

This medwatch is submitted to send the follow-up of the investigation of this complaint.Waiting for product return.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.Investigation still on progress.Conclusion not yet available.

Event Description

Mobi-c p&f us : implant looks loose before implantation.From information reported by the reporter: the implant was opened from packaging and loaded onto the inserter.The implant and inserter were handed to the surgeon who commented that the implant look loose and like it was going to fall apart.Surgeon asked for a brand new implant and didn¿t want to risk implanting what he thought was a faulty implant.We complied with the surgeon request and loaded a new implant no issue on loading or implanting the new implant.New implant was the same size and lot#.No harm to the patient.Update on december 31th 2018, according to the reporter: no delay more than 30 minutes on surgery.Implant properly loaded on the inserter.No difference in surgical steps between the first and the second implant.Additional information received from reporter on january 11th 2019: a photo of the implant loaded on inserter has been provided to the manufacturer.Additional information received from reporter on january 16th 2019: the superior piece was loose and had a lot of movement the surgeon didn't feel comfortable implanting it.

Event Description

During surgery, the surgeon reported a mobi-c implant looked loose/had too much toggle in the peek cartridge to use.Another implant was used to complete the surgery.There was no reported patient harm or additional impact to surgery.

Manufacturer Narrative

The mobi-c implant was returned assembled to the peek cartridge.It was found to be visually and functionally acceptable; no problems were detected, the complaint is not confirmed.There are no indications of manufacturing issues which would have contributed to this event.

• Brand Name: IMPLANT MOBIC M ST 15X17 H6 US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8225690
• MDR Text Key: 132371481
• Report Number: 3004788213-2019-00012
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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: MB3576
• Device Lot Number: 5295592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 48 YR