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.
[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
Report Number | 3004987282-2020-00016 |
MDR Report Key | 9908812 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-03-31 |
Date of Report | 2020-03-31 |
Date of Event | 2020-02-24 |
Date Added to Maude | 2020-03-31 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. NEAL DEFIBAUGH |
Manufacturer Street | 501 MERCURY DRIVE |
Manufacturer City | SUNNYVALE, CA |
Manufacturer Country | US |
Manufacturer G1 | SPINAL KINETICS LLC |
Manufacturer Street | 501 MERCURY DRIVE |
Manufacturer City | SUNNYVALE, CA |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | M6-C |
Generic Name | ARTIFICIAL CERVICAL DISC |
Product Code | MJO |
Date Received | 2020-03-31 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SPINAL KINETICS LLC |
Manufacturer Address | 501 MERCURY DRIVE SUNNYVALE, CA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-31 |