MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-16 for LATITUDE ULNAR CAP MEDIUM DKY068 4751AO019 manufactured by Tornier, Inc..
[5760817]
The hospital (b)(6) reported to tornier that the implant was explanted from the same pt due to aseptic loosening.
Patient Sequence No: 1, Text Type: D, B5
[13082386]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3004983210-2015-00005 |
MDR Report Key | 4616122 |
Report Source | 06 |
Date Received | 2015-03-16 |
Date Added to Maude | 2015-05-04 |
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 | 0 |
Event Location | 0 |
Manufacturer Contact | KEVIN SMITH |
Manufacturer Street | 10801 NESBITT 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 | LATITUDE ULNAR CAP MEDIUM |
Generic Name | NONE |
Product Code | KWH |
Date Received | 2015-03-16 |
Model Number | DKY068 |
Catalog Number | 4751AO019 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TORNIER, INC. |
Manufacturer Address | BLOOMINGTON MN US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2015-03-16 |