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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH SILICONE II MCP IMPLANT SIZE 50 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER
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STRYKER GMBH SILICONE II MCP IMPLANT SIZE 50 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER Back to Search Results
Model Number MCP-50
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/11/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event or Problem Description
It was reported the initial implant failed, broke apart; revision surgery was performed.
 
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Brand Name
SILICONE II MCP IMPLANT SIZE 50 (STERILE PACKED)
Common Device Name
PROSTHESIS, FINGER, CONSTRAINED, POLYMER
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ  2545
MDR Report Key12169744
Report Number0008031020-2021-00307
Device Sequence Number4580699
Product Code KYJ
UDI-Device Identifier00886385022178
UDI-Public00886385022178
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K870200
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberMCP-50
Device Catalogue NumberMCP50
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/28/2021
Initial Report FDA Received Date07/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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