MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X15 H5 US; CERVICAL DISC PROTHESIS

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

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

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Product still not returned to manufacturer.Examination is not performed yet.Review of the device history records and traceability shows no deviation or non-conformance in specification or procedures that may have impacted this event; investigation still in progress.Conclusion is not yet available.

Event Description

Mobi-c p and f us : disassembly on inserter.According to the reporter : the mobi c was put on the inserter when the surgical tech turned the knob too far and the implant disengaged falling on the mayo stand in 3 pieces.A new implant the same size was opened with no delay.No impact on the patient, no impact on the surgery or delay more then 30 min, the surgery was completed with another device of the same size.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Product was received and found compliant.Product examination confirmed the information of a user error provided by the reporter.The review of the device history records did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event.From information provided, based on the product history records, the recurrence of this type of event for this implant , it was assessed that the cause of the event is mishandling where the, scrub tech did not follow the instructions and turned the knob too far leading to the disassembly of the device.The mobi-c surgical technique warns to stop threading (the inner rod) as soon as full contact is achieved in order to avoid opening the disposable implant holder and releasing the implant.The investigation found no evidence to indicate device issue.Root cause : mishandling during assembly on inserter (instruction was not followed).

Event Description

An information was received on the (b)(6) 2018 about a disassembly incident occured during a c6/c7 antroplasty surgery.From the information provided by the reporter the device was on the inserter and the scrub tech turned the knob too far which disassembled the device.The device was immediately replaced by another one of the same size.The surgery was not delayed and there was no impact on the patient.

• Brand Name: MOBI-C IMPLANT 15X15 H5 US
• Type of Device: CERVICAL DISC PROTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7777604
• MDR Text Key: 117292218
• Report Number: 3004788213-2018-00282
• 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: 11/30/2018

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 Expiration Date: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5305113
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 40 YR