MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-04 for FUTURA CSI SUBTALAR IMPLANT DIAMETER 11 CSI-11 manufactured by Tornier Inc..
[93586795]
Patient Sequence No: 1, Text Type: N, H10
[93586796]
It was reported that the screw became loose at 3 days post-op.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004983210-2017-00029 |
MDR Report Key | 7078602 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2017-12-04 |
Date of Report | 2017-07-27 |
Date of Event | 2017-06-25 |
Date Mfgr Received | 2017-07-27 |
Date Added to Maude | 2017-12-04 |
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. DUSTIN SMITH |
Manufacturer Street | 10801 NESBIT AVE SOUTH |
Manufacturer City | BLOOMINGTON MN 55437 |
Manufacturer Country | US |
Manufacturer Postal | 55437 |
Manufacturer Phone | 9529217121 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | FUTURA CSI SUBTALAR IMPLANT DIAMETER 11 |
Generic Name | SUBTALAR PEG IMPLANT |
Product Code | MJW |
Date Received | 2017-12-04 |
Catalog Number | CSI-11 |
Operator | PHYSICIAN |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TORNIER INC. |
Manufacturer Address | 10801 NESBIT AVENUE SOUTH BLOOMINGTON MN 55437 US 55437 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2017-12-04 |