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

Catalog Number	CDM-625
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that an m6-c was implanted at c4/5 on (b)(6) 2021.The patient reported increased neck pain.The m6-c device was removed on (b)(6) 2023 due to suspected loosening of the device.
Additional Manufacturer Narrative
The device involved was not returned for evaluation.The build lhr was examined including the final inspection records and the in-process measurements.There was an ncmr associated with this lot, however, it was not related to this sn or failure reported.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Rmf 0003 rev 38 line 12.28 - migration/loosening, chronic, requiring additional surgery, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 38 line 12.63.- heterotopic ossification (grade 1 to 2), periarticular calcification and non-fusion.Rmf 0003 rev 38 line 12.75 - device explanted.It was reported that an m6-c was explanted due to suspected loosening of the device and the patient reported increasing neck pain.Radiographic images were provided for review.Ct images show disc replacement at c4/5 level and a fusion cage at c5/6 and c6/7 levels.No evidence of obvious loosening of the disc replacement.There is evidence of posterior heterotopic bone formation.X-rays show cervical spine with disc replacement at c4/5 with normal height and appropriately sized with no evidence of bone loss.There is a fusion from c5-c7 with cage and anterior plate and screw fixation.Intra-op images show disc replacement and fusion.The disc replacement has normal height, and the fusion cannot be determined due to anterior fixation but appears appropriately placed.Lateral view shows screw being placed in c4 vertebral body with the disc replacement still visible with minor bone loss along superior endplate.Microbiology/pathology reports and results were not provided.The device was not returned and examination of the explant could not be completed, therefore it is not possible to determine the cause of the reported failure for this product experience.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 17821427
• Report Number: 3004987282-2023-00057
• Device Sequence Number: 16754126
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2023

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: 01/31/2026
• Device Catalogue Number: CDM-625
• Device Lot Number: 1592873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• 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: 38 YR
• Patient Sex: Female