SILICONE II MCP IMPLANT SIZE 40 (STERILE PACKED) MCP40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-29 for SILICONE II MCP IMPLANT SIZE 40 (STERILE PACKED) MCP40 manufactured by Stryker Gmbh.

Event Text Entries

[93243825] Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition is unknown.
Patient Sequence No: 1, Text Type: N, H10


[93243826] Abolition of the joint space and the mcp ii silicone implant broke. Patient will go under revision surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0008031020-2017-00674
MDR Report Key7068287
Report SourceHEALTH PROFESSIONAL
Date Received2017-11-29
Date of Report2018-04-27
Date of Event2017-11-17
Date Mfgr Received2018-03-29
Device Manufacturer Date2013-09-12
Date Added to Maude2017-11-29
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 ContactMR. ROSE HAAS
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILICONE II MCP IMPLANT SIZE 40 (STERILE PACKED)
Generic NamePROSTHESIS, FINGER, CONSTRAINED, POLYMER
Product CodeKYJ
Date Received2017-11-29
Returned To Mfg2017-12-08
Catalog NumberMCP40
Lot Number23758401
Device Expiration Date2018-08-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-29

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