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

Model Number	CDL-637L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported disc at 5/6 had sign of rupture but it's difficult to tell what the state of the disc was in in-situ as surgeon causes further damage to the disc to get it out.Patient asymptomatic but osteolysis picked up on routine follow up imaging the nsi group all do here now.C5/6 and c6/7 foreign body osteolysis.Doctor performed c5/6-c6/7 subtotal vertebrectomy and r/o m6-c (x2).Redo c5/6 and c6/7 decompression iliac crest graft reconstruction.C5/6-c6/7 fixation.Per op report: both implants mobile and explanted.Rph histology multiple samples of tissue from osteolysis cyst.
Additional Manufacturer Narrative
Product has not been returned for investigation.Without product identifiers it is not possible to perform a review of lot history records.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.
Event or Problem Description
It was reported disc at 5/6 had sign of rupture but it's difficult to tell what the state of the disc was in in-situ as surgeon causes further damage to the disc to get it out.Patient asymptomatic but osteolysis picked up on routine follow up imaging the nsi group all do here now.C5/6 and c6/7 foreign body osteolysis.Doctor performed c5/6-c6/7 subtotal vertebrectomy and r/o m6-c (x2).Redo c5/6 and c6/7 decompression iliac crest graft reconstruction.C5/6-c6/7 fixation.Per op report: both implants mobile and explanted.Rph histology multiple samples of tissue from osteolysis cyst.
Additional Manufacturer Narrative
It was reported that the patient was asymptomatic, but osteolysis was observed on imaging during a routine follow-up done by the nsi group.The doctor performed c5/6-c6/7 subtotal vertebrectomy.Radiographic images were not provided for review.Microbiology/pathology reports and results were also not provided.The device was not returned and therefore examination of the explant could not be completed.With the information provided, it is not possible to determine the cause of the reported failure for this product experience.Should additional information be provided, the pe will be reopened and the investigation amended.Without a serial number, a review of the lhrs cannot be completed.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.

• Brand Name: M6-C
• Common Device Name: ARTIFICAL 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: 19512152
• Report Number: 3004987282-2024-00019
• Device Sequence Number: 12622839
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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 Model Number: CDL-637L
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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 Age: 51 YR
• Patient Sex: Female