MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H5 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); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
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: disassembly during insertion.C5-6 implanted device when he went to disengage cartridge would not come lose from disc.It pulled disc out tried to reload on cartridge couldn't so had to open another.Additional information was received on july 4th 2019: patient was not affected.The depth stop adjustment was set initially at zero.The surgical technique was followed at the mobi-c loading on inserter (take care to stop threading as soon as full contact is achieved in order to avoid premature opening of the peek cartridge and releasing the implant.) the disc space was under distraction.The surgeon didn't encounter resistance while inserting prosthesis.The prosthesis have not been inserted with an angle.No rotational move was done while inserting prosthesis.No difference in surgical steps between the first and the second implant.No per-op images are available.The surgeon didn't use the mobi-c no touch level.The surgeon use the mobi-c distraction forceps.Surgeon uses mobic a lot and there is usually a little resistance so he didn¿t think it would pull disc out completely.Product return was requested.Investigation still in progress.
Additional Manufacturer Narrative
The implant was returned for evaluation.The implant was received assembled and was connected to an inserter to determine if it would bind as reported.The implant was found to disassemble as expected by design.A review of the dhr did not identify any issues which would have contributed to this event.
Event or Problem Description
It was reported that a mobi-c implant would not disengage from the peek cartridge after insertion.It was then removed from the disc space and disassembled during removal.A different mobi-c was used to complete the surgery.There was no patient impact reported.

• Brand Name: IMPLANT MOBIC M ST 13X17 H5 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: 8801549
• Report Number: 3004788213-2019-00234
• Device Sequence Number: 327518
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: 3662663000093
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 09/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3375
• Device Lot Number: 5323770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 03/25/2020
• 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
• Patient Age: 36 YR
• Patient Weight: 52