MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Misassembled (1398); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report and the result of the investigation of this complaint.Information received from reporter confirmed that prosthesis disassemble upon detaching from inserter.Scrub tech tried first to attach to inserter upside down.The review of traceability and 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.From the information provided, based on the product history records, the review of the case and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.The root cause is related to a user error during insertion on inserter.As indicated into surgical technique : visual control of contact can be confirmed using the window on the implant inserter.The word up, indicating the top of the device, becomes completely visible when the correct position is obtained.If any further information is found which would change this evaluation, a reassessment will be performed.Product not returned.
Event or Problem Description
Mobi-c p&f us : disassembly prior insertion.It was reported by sales rep.That during a mobi-c surgery : the mobi-c implant became disassembled when scrub tech attempted to detach from the inserter and reattach in the proper orientation (with the word up in the window of the inserter).Prosthesis disassemble upon detaching from inserter.Scrub tech tried first to attach to inserter upside down.It was never placed in the patient.A new implant was selected and placed into patient without any problem.
Additional Manufacturer Narrative
The returned implant was examined.The components were confirmed to be detached from one another.The part was functionally tested.There was a gouge on the metal screw nut shaft that prevented reassembly, as the part no longer fit through the right peek jaw.Due to the fact that the product comes pre-assembled, it's reasonable to assume that this gouge was made after disassembly and was not the cause of the original disassembly.A probable cause of the retention feature failure can be attributed to the surgical tech over threading the inserter knob while initially loading the implant.This would cause premature opening of the peek cartridge and release of the implant.A review of the dhr did not find any issues which would have contributed to this event.The device's labeling provided instructions on attaching the assembled device to the inserter.
Event or Problem Description
It was reported that the implant disassembled when the scrub tech attempted to detach and reattach to the inserter.An alternate device was used to complete the case without reported patient harm.

• Brand Name: IMPLANT MOBIC M ST 15X17 H5 US
• Common Device Name: MOBI-C 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: 8690656
• Report Number: 3004788213-2019-00164
• Device Sequence Number: 16638017
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)230901(10)5321862
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: MB3575
• Device Lot Number: 5321862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 04/28/2020
• 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