MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  Injury  

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.Additional information were requested about the event.Conclusion is not yet available.Investigation still in progress.Device discarded by hospital.

Event Description

Mobi-c p&f us : disassembly.From information reported, the device was inserted "a quarter of the way in".An antero-posterior image was taken and surgeon decided to change trajectory.The device disassembled (superior plate and dome detached from cartridge) when implant was "backed out".Surgery was completed successfully with another device (same size).No impact on patient.Additional information was requested on the surgical steps involved.Investigation is in progress.

Event Description

Mobi-c p&f us : disassembly.The implant was removed under light distraction.The surgeon gently pulled the implant out pulling slightly more to one sight then the other, but it immediately came off the cartridge.There was slight resistance as the implant was inserted under light distraction.

Manufacturer Narrative

This medwatch is submitted following an additional information that was received and to send result of the investigation.The implant was removed under light distraction.The surgeon gently pulled the implant out pulling slightly more to one sight than the other, but it immediately came off the cartridge.There was slight resistance as the implant was inserted under light distraction.The implants teeth were not set in the bone.The review of the device history records and traceability did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event.The investigation of this case found that the root cause of device disassembly is not device related.The investigation found no evidence to indicate a device issue.After analysing the information received , the root cause is to be an user error (repositioning) as mentioned in the surgical technique ( step 11) - during and after insertion, avoid lateral and rotational movements of the implant-to-peek cartridge assembly.

• Brand Name: MOBI-C IMPLANT 15X19 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
• MDR Report Key: 7454387
• MDR Text Key: 106286566
• Report Number: 3004788213-2018-00123
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5289795
• Other Device ID Number: (01)03662663000185(17)220401(1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR