MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SBI MCP SILICONE IMPLANT; PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number UNK_SEL

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

As reported: "revision of stryker/sbi mcp silicone implant due to implant breaking in patient.".

• Brand Name: UNKNOWN SBI MCP SILICONE IMPLANT
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13157807
• MDR Text Key: 285065705
• Report Number: 0008031020-2022-00003
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female