M6-C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for M6-C manufactured by Spinal Kinetics Llc.

Event Text Entries

[189002818] Without a lot number, the device history records review could not be completed. Additional information and the return of the device has been requested. This was a two-level implantation. In the us, the m6-c artificial cervical disc is indicated for use following a single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from c3 - c7. The ifu states that the safety and effectiveness of the m6-c artificial cervical disc has not been established in patients with more than one cervical level requiring surgery.
Patient Sequence No: 1, Text Type: N, H10


[189002819] It was reported that a patient with 2 m6-c artificial cervical discs was revised. The second device has now been removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004987282-2020-00016
MDR Report Key9908812
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-24
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. NEAL DEFIBAUGH
Manufacturer Street501 MERCURY DRIVE
Manufacturer CitySUNNYVALE, CA
Manufacturer CountryUS
Manufacturer G1SPINAL KINETICS LLC
Manufacturer Street501 MERCURY DRIVE
Manufacturer CitySUNNYVALE, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameM6-C
Generic NameARTIFICIAL CERVICAL DISC
Product CodeMJO
Date Received2020-03-31
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSPINAL KINETICS LLC
Manufacturer Address501 MERCURY DRIVE SUNNYVALE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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