MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; STERILE CERVICAL DISC PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.Product was not returned yet, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.
Event or Problem Description
Mobi-c p&f us: disassembled during repositioning.The surgeon was implanting the implant (with distraction) and decided he needed to reposition the implant after it was only implanted 50% of the way.He opened the caspar retractor to the maximum.When the surgeon pulled his hand back to pull the implant out, the lower plate came loose from the peek cartridge.The surgery was completed with another device of the same size.No surgery impact or serious injury were reported.Additional information was requested.Investigation still in progress.
Additional Manufacturer Narrative
Corrections to: a1, a2 age, b3, b5, d4 udi number, d10, e1, e2, e3, h1, h3, h6: device, method, and results codes.Additional information in: a3, g5: pma number.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that during surgery, the bottom plate of the mobi-c implant disassembled from the inserter when the surgeon went to re-position the implant during insertion.The implant was removed and a new implant was used in its place.No impact to the patient was reported.
Additional Manufacturer Narrative
The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.
Event or Problem Description
It was reported that during surgery, the bottom plate of the mobi-c implant disassembled from the inserter when the surgeon went to re-position the implant during insertion.The implant was removed and a new implant was used in its place.No impact to the patient was reported.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Common Device Name: STERILE CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8801512
• Report Number: 3004788213-2019-00235
• Device Sequence Number: 327283
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: 03662663000000
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2020

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: MB3355
• Device Lot Number: 5327636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 12/30/2019; 05/06/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 01/29/2020; 06/04/2020
• 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: 47 YR