MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H6 US; CERVICAL DISK PROSTHESIS

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Product was not received by the manufacturer.No visual examination could be performed.As described " scrub tech placed implant on inserter incorrectly and it came apart".No harm to patient.No unanticipated surgical complication occured.No surgery delay.The surgery was completed with another implant.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 review of the case found that root cause is related to an user error.As reported the disassembly is related to an incorrect positioning of the implant on inserter.The investigation found no evidence on a product issue.Device not returned to the manufacturer.

Event Description

Mobi-c p&f us : disassembled on inserter.Srub tech placed implant on inserter incorrectly and it came apart.No delay of more than 30 min has been reported.A new implant was used to complete the surgery.No impact on the patient.

• Brand Name: MOBI-C IMPLANT 15X17 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7827328
• MDR Text Key: 118613037
• Report Number: 3004788213-2018-00250
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2018

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: MB3576
• Device Lot Number: 5304161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1