MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-21 for M6-C manufactured by Spinal Kinetics Llc.
[184460924]
Without a lot number, the device history records review could not be completed. Additional information and the return of the device has been requested. Additional information and the return of the device has been requested.
Patient Sequence No: 1, Text Type: N, H10
[184460925]
It was reported that a patient with an m6-c artificial cervical disc presented with radiculopathy and the surgeon has planned a revision.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004987282-2020-00012 |
MDR Report Key | 9863278 |
Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
Date Received | 2020-03-21 |
Date of Report | 2020-03-20 |
Date of Event | 2020-02-20 |
Date Mfgr Received | 2020-02-20 |
Date Added to Maude | 2020-03-21 |
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 | 2020-03-21 |
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 | 2020-03-21 |