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	Unspecified Infection (1930)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is being returned to manufacturer for investigation but not yet received.
Event or Problem Description
It was reported there was a removal of an m6-c device at c6/7.Surgeon origionally thought osteolysis present but upon commencement of the procedure he now thinks infection was the cause.There was a large collection of pus.Patient has a 2 level m6 implanted on (b)(6) 2024 at c5/6-c6/7 but only the lower level was removed.
Additional Manufacturer Narrative
Device was returned for investigation.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data and images provided, while the device was heavily damaged during removal, the device did not fail mechanically in vivo.There was no evidence of collapse and little in vivo damage.It was reported that infection was suspected and a large amount of pus was visible during the revision surgery.A cystic lesion was observed in the pre-revision image, consistent with osteolysis.It is likely that infection contributed to the observed osteolysis; however, due to the extent of the extraction damage, it is unclear if in vivo damage to the fiber construct may have contributed, as well.Therefore, the failure of this procedure was likely due to the observe infection and subsequent osteolyisis; however, at the time of removal, the device was likely still functional and had not failed.Rmf 0003 rev 38 line 12.73.1.- resorption or osteolysis, with known or suspected infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 38 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 there was a removal of an m6-c device at c6/7.Surgeon originally thought osteolysis present but upon commencement of the procedure he now thinks infection was the cause.There was a large collection of pus.Patient has a 2 level m6 implanted on (b)(6) 2024 at c5/6-c6/7 but only the lower level was removed.

• 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: james stephens ; 501 mercury dr; sunnyvale 94085
• MDR Report Key: 19469429
• Report Number: 3004987282-2024-00018
• Device Sequence Number: 20707400
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 12/21/2025
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 1583466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/12/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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: 47 YR
• Patient Sex: Male