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

Model Number 6MM LARGE LONG

Device Problem Compatibility Problem (2960)

Patient Problems Dysphagia/ Odynophagia (1815); Unspecified Infection (1930)

Event Date 05/13/2022

Event Type  Injury  

Event Description

Three-level patient presented with fluid collection anterior to and to the left of mid-level implant.An m6-c implant was removed to replace and wash out the involved level.The device was explanted.The condition of the device at the time of removal was unknown.

Manufacturer Narrative

Additional information has been requested.The surgeon had reportedly not retrieved the implant after removal; therefore, the device will not be returned for evaluation.A review of the lot history records for this device did not reveal any non-conformances to specification or deviations in procedure.The risk management files were reviewed and no new risks were identified.

Manufacturer Narrative

No radiographic images and microbiology/pathology reports provided for review.Review of lhr did not reveal any non conformance for the lot number and serial number.Based on the inspection of the retrieved m6-c implant, in conjunction with data provided, the device had not failed mechanically at the time of removal.There was no evidence of collapse and there was no apparent in vivo loss of retention of the sheath.Destructive examination of the inner surfaces of the device is needed to examine the integrity of the fiber construct and the core.It was reported that infection was suspected, which may have contributed to the noted fluid absorption; however, no lab results were provided.It is therefore not clear if infection played a role in the failure of this procedure.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; spinal kinetics llc; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS LLC; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085 ; 2149372015
• MDR Report Key: 14757006
• MDR Text Key: 294591031
• Report Number: 3004987282-2022-00047
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2024
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: 1299102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male