MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H7 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
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 did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Investigation still in progress.
Event or Problem Description
Mobi-c p&f us: disassembled during impaction.As reported by sales rep ((b)(4)), upon impaction 15x15x17 implant came apart.Replaced with a 15x15x6 implant which dr.Said was flimsy on inserter.Ultimately, chose to fuse.Additional information was requested.Investigation ongoing.
Additional Manufacturer Narrative
The returned implant was examined.The device was disassembled.Further testing did not reveal any deformation to cause the disassembly.Retention feature failures of this nature have previously been attributed to clinicians overturning the impaction knob, loosening the implant from the peek cartridge.These failures have also previously been attributed to increased forces experienced by the implant from surrounding tissues due to clinicians performing lateral/rotational movement while inserting into the disk space, incorrect sizing of the implant, inadequate distraction, and/or inadequate preparation of the of the disc space.However, since the cartridge screw was not returned, and without intra-op images, the exact cause cannot be conclusively determined.
Event or Problem Description
It was reported that the mobi-c implant disassembled during surgery, while impacting the device into the final location.The surgeon chose to switch to fusion and no further patient impact was reported.

• Brand Name: IMPLANT MOBIC M ST 15X15 H7 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8735444
• Report Number: 3004788213-2019-00198
• Device Sequence Number: 2573220
• Product Code: MJO
• UDI-Device Identifier: 03662663000086
• UDI-Public: 03662663000086
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3557
• Device Lot Number: 5281649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/25/2020
• 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