MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 17X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems Material Separation (1562); Misassembly by Users (3133)

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

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

Product not received yet by manufacturer.No examination was performed.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The implant is going to be returned and evaluation is still pending.Device not received yet by manufacturer.

Event Description

Mobi-c p&f us : disassembly.From information provided, implant "fell apart when scrub was attaching it to the inserter.All occured prior to touching patient." no delay of more than 30 min has been reported.The surgery was completed successfully with another implant of the same size.No impact on the patient.Additional information was received on july 31st, 2018 : according to reporter, the surgical technique was followed while loading device on inserter.

Event Description

Mobi-c p&f us : dissassembly.From information provided, implant fell apart when scrub was attaching it to the inserter.All occured prior to touching patient.No delay of more than 30 min has been reported.The surgery was completed successfully with another implant of the same size.No impact on the patient.Additional information was received on (b)(6), 2018 : according to reporter, the surgical technique was followed while loading device on inserter.Additional information received on january 31th 2019 : product has been returned to the manufacturer and a actual product evaluation has been performed.

Manufacturer Narrative

This medwatch is submitted to send the final report.Additional information received on (b)(6) 2019 : product has been returned to the manufacturer and it was evaluated by the r&d department.From information provided, based on the product history records, the review of the case, after having performed product evaluation and the recurrence of this type of event for this implant, the likely cause for the event is a mishandling when loading the device on inserter.It appears that the surgeon didn't follow the instructions (step 9 loading the prothesis).The investigation found no evidence to indicate a device issue.Root cause is related to mishandling during prothesis /inserter assembly.

• Brand Name: MOBI-C IMPLANT 17X17 H6 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: 7796538
• MDR Text Key: 117566685
• Report Number: 3004788213-2018-00284
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3776
• Device Lot Number: 5306476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 38 YR