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

Catalog Number	CDL-635L
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that an m6-c artificial cervical disc was implanted at c5/6 in 2014.The m6-c was explanted on (b)(6) 2024 due to patient experiencing dysphagia with osteolysis seen on ct.
Additional Manufacturer Narrative
Additional information has been requested.A review of the lot history record cannot be performed without the serial/lot number.A review of the risk management files was performed and no new risks have been identified.Rmf 0003 rev 38 line 19.2.- dysphagia, hoarseness/dysphonia, vocal chord paralysis, airway obstruction, leading to major/surgical intervention, with explantation.Rmf 0004 rev 24 line 9.73.1 - resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention, with explantation.Rmf 0004 rev 24 line 9.77 - device explanted.
Additional Manufacturer Narrative
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.Rmf 0003 rev 38 line 19.2.- dysphagia, hoarseness/dysphonia, vocal chord paralysis, airway obstruction, leading to major/surgical intervention, with explantation rmf 0003 rev 38 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 38 line 12.75 - device explanted.It was reported that an m6-c was explanted, as the patient became dysphagic and the ct scan showed osteolysis.Radiographic images were provided for review.The ct image shows the cervical spine.The cervical spine has lost its lordosis.The image shows the disc replacement at the c5/6 level and appears to have lost height.There are large cystic erosions posteriorly both at c5 and c6.There is also evidence of severe degenerative changes and large osteophytes at c3/4 and c4/5 and c6/7.The mri image shows the disc replacement has collapsed with large bony erosions along both endplates.It also confirms sever degenerative changes at the surrounding levels.Microbiology/pathology reports and results were not provided.The device was not returned and therefore examination of the explant could not be completed.While it was confirmed that the device had collapsed, without examination of the device, 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 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale 94085
• MDR Report Key: 18771651
• Report Number: 3004897282-2024-00003
• Device Sequence Number: 18119469
• Product Code: MJO
• UDI-Device Identifier: 00812388030025
• UDI-Public: 00812388030025
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 12/18/2018
• Device Catalogue Number: CDL-635L
• Device Lot Number: 1404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 43 YR
• Patient Sex: Male