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 2020-02-06 for M6-C 6MM LARGE CDL-627 manufactured by Spinal Kinetics Llc.
[178116976]
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. This is one (1) of two (2) reports submitted on this event.
Patient Sequence No: 1, Text Type: N, H10
[178116977]
It was reported a two-level patient was revised. Both devices were explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004987282-2020-00006 |
| MDR Report Key | 9679468 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2015-10-22 |
| Date Added to Maude | 2020-02-06 |
| 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 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer G1 | SPINAL KINETICS LLC |
| Manufacturer Street | 501 MERCURY DRIVE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| 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 | 2020-02-06 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 6MM LARGE |
| Catalog Number | CDL-627 |
| Lot Number | 5489 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |