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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer.No examination can be performed.As described by the reporter " the surgeon tried to reposition the implant in the disc space and the implant fell apart therefore another implant from the same size was used to continue the surgery.The reporter mentioned on 28th february 2018 that there was no over distraction prior to the implantation.No impact on patient state of health was reported.The surgery was delayed about 5 min.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.Review of the case showed that probable root cause of this event is absence of distraction prior implant positioning.As reporter mentioned there was anterior to posterior motions to reposition the implant however the surgeon had trouble adjusting the implant position due to tight disc space.The investigation found no evidence of a device issue.In addition, investigation led to a user error during repositioning.The surgeon did not follow instruction by not applying a distraction prior to the repositioning.

Event Description

Mobi-c p and f us : disassembly.It was a mobi-c two level c4-6 surgery.From provided information "the dr tried to reposition the implant in the disc space and the implant fell apart.A new implant with same size was used to complete the surgery.No impact on the patient was reported.Surgery was delayed about 5 min.In addition the reporter mentioned that : he confirmed tightening with the tech to not over tighten but ensure that peek was secured on inserter with no movement.While physician was adjusting implants there was no rotation, the motions were strictly anterior to posterior.The physician had trouble adjusting due to a tight disc space.The space was not over distracted prior to implantation.Update on 28 th february 2018 : no other distraction was done post reposition.

Manufacturer Narrative

Additional information received on reference and lot number of implant: the mobi-c that was wasted is mb3555 / lot 5297201 and not mb3575 / lot: 5288636.Investigation and previous root cause identified remains unchanged.

Event Description

Additional information received on reference and lot number of implant: the mobi-c that was wasted is mb3555 / lot 5297201 and not mb3575 / lot : 5288636.

• Brand Name: MOBI-C IMPLANT 15X15 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
• 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: 7365991
• MDR Text Key: 103321319
• Report Number: 3004788213-2018-00072
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5297201
• Other Device ID Number: (01)03662663000062(17)220801(0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2017
• 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
• Patient Age: 52 YR