MAUDE Adverse Event Report: SPINAL KINETICS M6-C; ARTIFICIAL CERVICAL DISC

Model Number	CDL-637L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Orthofix received a notification from the fda for report mw5169519 that was received through fda medwatch program.The report describes the problem as m6 failed implant.The implant was "spinning" out.Implant had to be surgically removed.
Additional Manufacturer Narrative
Additional information has been requested but the device will not be returning.A follow up will be submitted if new information is provided.
Additional Manufacturer Narrative
It was reported that an m6 implant had failed and had to be explanted.However, radiographic images or clinical information were not provided for review.The device was not returned and therefore examination of the explant could not be completed.With the limited information provided, it is not possible to determine the cause of the reported failure for this product experience.Without a serial number or lot number, a review of the lhr and ncmr database cannot be completed.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
Orthofix received a notification from the fda for report mw5169519 and mw516520 that was received through fda medwatch program.The report describes the problem as m6 failed implant.The implant was "spinning" out.Implant had to be surgically removed.Note= mw5169519 and mw516520 are duplicate reports submitted with identical information.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: ayesa kearns ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 22145554
• Report Number: 3004987282-2025-00013
• Device Sequence Number: 7343153
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CDL-637L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown