MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 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 01/11/2018

Event Type  Injury  

Manufacturer Narrative

The review of the inspection records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Not received yet.

Event Description

Mobi-c p and f us : disassembly.The implant fell apart while putting on inserter.Another implant of the same size was inserted with the same inserter without problem.No harm for patient.Waiting for additional information.

Event Description

Mobi-c p&f us : disassembly according to the reporter , ther was no impact on patient.During a surgery mobi-c implant fell apart while putting on inserter and inserter was not over tightened.According to the reporter knob on back was barely turned and implant fell apart so they had to use another one in its place.Additional information received from the reporter (distributor) on (b)(6) 2018 : there were no problems with the second implant.The second implant was inserted with the same inserter and according to him surgical steps were followed same way.Additional information received from the reporter (distributor) on (b)(6) 2018 : according to him nothing was wrong with the packaging or the prothesis when the event occured.Update on (b)(6) 2018 : the sales order was received and shows additional informations : the patient information.Associated products.Customer information.Although the reporter mentioned that the device will be returned , it was never received by the manufacturer.

Manufacturer Narrative

Additional information has been provided on (b)(6) 2018 : the sales order has been received and confirmed the device reference and lot number.Although it was mentioned that the prothesis will be returned to the manufacturer.It was never received for examination.The review of the device history records and traceability shows no evidence on a device issue that may have impacted this event.Based on the product history records, the review of the case, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.The cause for the device disassembly remain undetermined the description received reflect the possibility that the disassembly occured for poor assembly of the device on the inserter.However regarding the lack of provided data this assumption cannot be validated.If additional information were received , another report will be sent.

• Brand Name: MOBI-C IMPLANT 15X17 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: 7276762
• MDR Text Key: 100269041
• Report Number: 3004788213-2018-00039
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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: MB3575
• Device Lot Number: 5291499
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 59 YR