MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H5 US; CERVICAL DISK PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch is submitted to send the results of the investigation: this medwatch complete the informations provided in the mdr reference 3004788213-2018-00050.Product was returned without decontamination form which prevent it's examination.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.From information initially provided, the problem came from the hospital technician who exceeded the threading limit causing the implant to fall off the inserter.Another implant was used and no delay was reported.The surgery was completed successfully with another implant of the same size.No impact on the patient.As mentioned in the surgical techniques : step 9 take care to stop threading as soon as full contact is achieved to avoid premature opening of the peek cartridge and releasing the implant.The investigation found no evidence to indicate device issue.Root cause: mishandling during implant assembly on the inserter.Returned in incomplete state.
Event or Problem Description
Mobi-c p&f us: disassembly.It was a cervical disc replacement.Issue occured while loading the implant on the inserter.As described by reporter : the hospital surgical technologist threaded the implant off the inserter.Another implant was used to complete the surgery successfully.No impact on patient.

• Brand Name: MOBI-C IMPLANT 15X19 H5 US
• Common Device Name: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8712561
• Report Number: 3004788213-2019-00177
• Device Sequence Number: 2662932
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: 03662663000185
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: MB3595
• Device Lot Number: 5279995
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 06/19/2019
• 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: 57 YR