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

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report and the investigation results for this case: product was not returned to manufacturer, product discarded by the hospital, no examination was performed.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.From information provided by the reporter, based on the product history records, it is assessed that the event is due to surgeon mishandling while repositioning the device.Indeed, as described , when the surgeon was trying to adjust the implant, it disassembled.It points out that the surgeon probably did not follow the instructions mentioned in the surgical techniques, and did not apply a new distraction before trying to reposition the device.As indicated in st : if necessary to correct a rotated device or for lateral implant adjustments, distraction of the disc space is required to prevent implant-to-peek cartridge disassembly in situ.In addition , the surgeon did'nt use the mobi-c no touch level to verify the implant trajectory as mentioned in surgical technique step 10.Indeed to verify the correct position and axial rotation about the transverse plane of the implant inserter, use the inserter level (mb9072r).The use of this instrument would have helped the positioning and prevent the adjustment from the beginning.The investigation found no evidence to indicate a device issue.
Event or Problem Description
Mobi-c p&f us: disassembled during adjustment.It was reported by a sales representative during a mobi-c surgery that surgeon placed implant and when she went to adjust and tap in it fell apart.No injury to patient reported.A delay of 10 min occured.Surgery was completed with a device of same size without further complication.Additional informations were received on may 30th : patient is healthy.The level implanted was c3/c4.The depth stop adjustment set initially at zero.The surgical technique was followed at the mobi-c loading on inserter.The surgeon did not encounter resistance while inserting prosthesis.The surgeon did not use the mobi-c no touch level and the mobi-c distraction forceps.Surgery completed with a new implant of the same size without further complication.

• Brand Name: MOBI-C IMPLANT 15X19 H5 US
• Common Device Name: 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: 8690372
• Report Number: 3004788213-2019-00157
• Device Sequence Number: 16557794
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: 03662663000185
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5324609
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 42 YR