SILICONE MCP SZ 10 SMCP-500-10-WW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-22 for SILICONE MCP SZ 10 SMCP-500-10-WW manufactured by Ascension Orthopedics.

Event Text Entries

[83241262] To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10


[83241263] Four of 4 reports. Other mfg report numbers: 1651501-2017-00033,1651501-2017-00034,1651501-2017-00035. It was reported that the initial silicone mcp arthroplasty was performed on (b)(6) 2016. Revision case was scheduled for (b)(6) 2017; once the surgeon noticed that the index finger of the implants had failed, he decided to check all of the other implants (middle finger, ring finger, & small finger) had also failed or almost failed. The index finger silicone implant had broken at the hinge/distal stem of the size 20 implant. This happened as well to the middle finger size 20 implant. The size 10 ring finger implant had not completely failed but it had a visible cut at the hinge/distal stem section. The size 10 small finger implant failed in the same fashion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1651501-2017-00036
MDR Report Key6810387
Report SourceUSER FACILITY
Date Received2017-08-22
Date of Report2017-08-04
Date of Event2017-08-04
Date Mfgr Received2017-09-12
Date Added to Maude2017-08-22
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 ContactUSER SONIA IRIZARRY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1ASCENSION ORTHOPEDICS
Manufacturer Street8700 CAMERON ROAD #100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal Code78754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILICONE MCP SZ 10
Generic NameSILICONE MCP
Product CodeKYJ
Date Received2017-08-22
Returned To Mfg2017-08-30
Catalog NumberSMCP-500-10-WW
Lot Number152843T
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer Address8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-08-22

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