MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 07/16/2018

Event Type  malfunction  

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.(b)(4).Additional informations were requested.Investigation still in progress.Conclusion not yet available.Product not returned yet.

Event Description

Mobi-c p&f us : issue while loading on inserter.Implant would not load properly on inserter.It kept loading crooked and had too much toggle.Physician was not comfortable implanting so he opened another implant of the same size.Upon inspection, the implant was loose and toggling in peek implant casing.The surgery was completed successfully with another implant.More information was requested.

Manufacturer Narrative

Fields were updated.Product not received at ldr medical: no visual & functional examination was performed.The review of the device history records and the traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Update received still unsufficient to determine the root cause of the event.Additional request were made to the reporter to find out if the product will be returned as mentioned in the complaint report.Investigation still in progress, conclusion is not yet available.

Event Description

Mobi-c p&f us: issue while loading on inserter.Update received by the reporter on the (b)(6) 2018.The entire implant was loose on the inserter.It loaded crooked on the inserter and looked as though it was not assembled correctly.Another implant of the exact same size was opened and it loaded fine the first try.The surgical technique followed at the mobi-c loading on inserter.The reporter is not aware of the current state of health of the patient.Investigation still in progress.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was found that during surgery, a mobi-c implant had too much toggle when attempting to load onto the inserter.Another implant of the same size was used in its place.There was no patient or surgical impact reported.

• Brand Name: IMPLANT MOBIC M ST 13X17 H6 US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7780030
• MDR Text Key: 116994261
• Report Number: 3004788213-2018-00283
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3376
• Device Lot Number: 5270724
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 24 YR