MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-10 for ACADIA FACET REPLACEMENT manufactured by Globus Medical.
[75168284]
Frequent back problems.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5069720 |
MDR Report Key | 6562814 |
Date Received | 2017-05-10 |
Date of Report | 2017-05-10 |
Date of Event | 2017-03-15 |
Date Added to Maude | 2017-05-12 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | PATIENT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | ACADIA FACET REPLACEMENT |
Generic Name | APPLIANCE FIXATION SPINAL INTERLUMINAL |
Product Code | MRW |
Date Received | 2017-05-10 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 0 |
Device Event Key | 0 |
Manufacturer | GLOBUS MEDICAL |
Brand Name | ACADIA FACET REPLACEMENT |
Generic Name | APPLIANCE FIXATION SPINAL INTERLUMINAL |
Product Code | MRW |
Date Received | 2017-05-10 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | GLOBUS |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2017-05-10 |