MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT HOLDER; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Mechanical Problem (1384); Material Separation (1562); Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Product not yet returned to manufacturer.No examination was yet performed the review of the traceability and the device history records is in progress to find if there is any non-conformances to specifications or deviations in procedures that might have contributed to the reported event investigation still in progress.Conclusion is not available yet.Device not received yet.

Event Description

Mobi-c p&f us : malfunction mb9001r as reported : " implant was attached to the inserter, the inserter was set to zero.Surgeon inserted the implant into the patient and the implant ended up too far posterior as if the inserter was not set to zero.Upon trying to pull the implant back, the implant came apart.The inserter was checked and it was still set to zero.A new implant and different inserter was used.Same process and had no troubles." no impact on patient.Delay 2 min.Additional information requested investigation still in progress.

Manufacturer Narrative

The returned device was examined.Visual inspection showed no obvious signs of damage.A functional test was conducted and found the device to be fully functional, therefore, the failure was not confirmed.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during surgery, the surgeon inserted the implant too far posteriorly.Upon trying to remove the implant, it disassembled.A new implant and inserter were used in the originals places without any further issues.

• Brand Name: IMPLANT HOLDER
• 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: 7761731
• MDR Text Key: 116391403
• Report Number: 3004788213-2018-00237
• 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
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MB9001R
• Device Lot Number: 410157503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1