MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-05 for M6-C 7MM LONG LARGE CDL-737L manufactured by Spinal Kinetics Llc.
[189002336]
A review of the lot history records for this device did not reveal any non-conformances to specification or deviations in procedure. Additional information 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
[189002337]
It was reported a two-level patient was revised. One device was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004987282-2020-00009 |
| MDR Report Key | 9795269 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-05 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-04-22 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 7MM LONG LARGE |
| Catalog Number | CDL-737L |
| Lot Number | 1289396 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-05 |