MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-09-28 for SWANSON FINGER 470000X manufactured by Wright Medical Technology, Inc..
[55809310]
The investigation is not complete. Trends will be evaluated. This report will be updated when the investigation is complete. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[55809311]
Allegedly, pip implant rupture joint forefinger. Laxity ---> implant exchange. Prostheses exchange stabilization op.
Patient Sequence No: 1, Text Type: D, B5
[60101274]
This incident is considered closed. If at any time new or updated information becomes available, the incident will be re-opened and investigated.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1043534-2016-00111 |
MDR Report Key | 5983162 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2016-09-28 |
Date of Report | 2016-09-28 |
Date of Event | 2016-09-15 |
Date Facility Aware | 2016-09-15 |
Date Mfgr Received | 2016-09-15 |
Date Added to Maude | 2016-09-28 |
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 Street | 1023 CHERRY ROAD |
Manufacturer City | MEMPHIS TN 38117 |
Manufacturer Country | US |
Manufacturer Postal | 38117 |
Manufacturer Phone | 901451-631 |
Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
Manufacturer City | ARLINGTON TN 38002 |
Manufacturer Country | US |
Manufacturer Postal Code | 38002 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SWANSON FINGER |
Generic Name | SMALL JOINT COMPONENT |
Product Code | KWF |
Date Received | 2016-09-28 |
Catalog Number | 470000X |
Lot Number | NI |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2016-09-28 |