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

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Osteolysis (2377)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

Additional information and the return of the device have been requested.Without a device, serial number, or lot number, the device history records review could not be completed.Histopathology laboratory reports concluded the following observations: advanced degenerative altered disc at c7/t1 level and no active inflammation.The tissue at c5/c6 level: degraded components of the intervertebral disc and foreign body reaction with polyethylene abrasion, analogous to a periprosthetic membrane of the abrasion-induced type (type i according to moraweitz).Tissue at c4/c5 level, originating mainly from the ligaments of the spine with pronounced foreign body reaction with polyethylene and metal abrasion analogous to a perioprothelial membrane of the abrasion-induced type.(type i according to moraweitz).No suspicion of malignancy in all fractions.This is one (1) of two (2) reports submitted for this event.

Event Description

Two m6-c devices explanted due to infection.Both devices were explanted.The condition of the devices at the time of removal is unknown.

Manufacturer Narrative

The radiographic images showed disc replacements at c4/c5 and c5/c6 had evidence of osteolytic changes at both levels with lost height observed.A large cyst of the c5 vertebral body extending to the inferior endplate at the c4/c5 level was observed.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 13690432
• MDR Text Key: 286732997
• Report Number: 3004987282-2022-00021
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 58 YR
• Patient Sex: Male