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

Model Number	CDM-625
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been returned for investigation and is pending completion.Based on the inspection of the retrieved m6-c, in the absence of additional clinical data or interim radiographs, the cause of this event was unclear.It is unknown if infection was suspected or confirmed, which may have contributed to the observed osteolysis at the adjacent level.While some in vivo damage was noted on the core, the majority of the damage appeared to be extraction damage.Due to the extent of the extraction damage and lack of additional clinical or radiographic information, it is unclear if this device had failed mechanically at the time of removal.Further, mechanical failure and osteolysis of the m6-c at the adjacent level likely contributed to the removal of this device.Rmf 0003 rev 39 line 12.22.- migration/loosening, acute requiring additional surgery, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 39 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.The build lhr was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.
Event or Problem Description
It was reported that there was a removal of c3/4 and c4/5 m6-c implanted in 2021 - south african patient - probably first implanted there.
Additional Manufacturer Narrative
Device has been returned for investigation and is pending completion.
Event or Problem Description
It was reported that there was a removal of c3/4 and c4/5 m6-c implanted in 2021 - south african patient - probably first implanted there.

• Brand Name: M6 CERVICAL
• 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: avinash thite ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 20304354
• Report Number: 3004987282-2024-00030
• Device Sequence Number: 15389754
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 Expiration Date: 01/01/2024
• Device Model Number: CDM-625
• Device Catalogue Number: FG0005-10
• Device Lot Number: 1277328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2019
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Weight: 76 KG