SWANSON FINGER 470000X

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1043534-2016-00111
MDR Report Key5983162
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2016-09-28
Date of Report2016-09-28
Date of Event2016-09-15
Date Facility Aware2016-09-15
Date Mfgr Received2016-09-15
Date Added to Maude2016-09-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street1023 CHERRY ROAD
Manufacturer CityMEMPHIS TN 38117
Manufacturer CountryUS
Manufacturer Postal38117
Manufacturer Phone901451-631
Manufacturer G1WRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Street11576 MEMPHIS ARLINGTON RD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWANSON FINGER
Generic NameSMALL JOINT COMPONENT
Product CodeKWF
Date Received2016-09-28
Catalog Number470000X
Lot NumberNI
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-09-28

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