MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X15 H6 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
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.Not returned to manufacturer yet.
Event or Problem Description
Mobi-c p&f us: disassembly during releasing.Mobic was attempted to be implanted at c6/7.After proper surgical technique was observed the implant released from the peek cartridge difficult.Once the peek cartridge was finally removed with the forceps, the top endplate was twisted.Attempt was made to correct the malfunction with no success.Implant was inserted under fluoroscopy confirming correct orientation.A new implant was opened and used, implanted successfully.Additional information was received: patient is doing well.The depth stop adjustment was set initially at zero.Surgical technique was followed at the mobi-c loading on inserter the disc space was under distraction.No resistance while inserting prosthesis.The prosthesis was not inserted with an angle.No rotational move was done while inserting prosthesis.X-ray was used to carefully implant.No difference in surgical steps between the first and the second implant.No per-op images are available.The mobi-c no touch level was not used.The mobi-c distraction forceps was used.Resistance was not met in step -while removing peek jaws if there is any resistance, one of the jaw may be against the uncus.The step.Rotate the convex jaw first (as it is the less bulky) by 90° caudal & pull it back along the disc axis (see image below)- was not required.Investigation ongoing.
Event or Problem Description
It was reported that during surgery, upon inserting the implant, there was difficulty releasing the implant from the cartridge.The peek cartridge was removed and it was found that the top endplate was twisted.The implant was removed and a new implant was used in its place.There was no patient or surgical effect 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.

• Brand Name: IMPLANT MOBIC M ST 15X15 H6 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: 8835336
• Report Number: 3004788213-2019-00252
• Device Sequence Number: 14142077
• Product Code: MJO
• UDI-Device Identifier: 03662663000079
• UDI-Public: 03662663000079
• 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): 06/29/2020

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: 03/01/2020
• Device Model Number: N/A
• Device Catalogue Number: MB3556
• Device Lot Number: 5243879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 06/29/2020
• 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: 35 YR