MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE MCP SZ 40

Catalog Number SMCP-500-40-WW

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported a multiple joint silicone mcp procedure was performed on (b)(6) 2014.During billing it was discovered one of the implanted devices had expired.The distributor immediately informed the customer that an expired device had been used.The customer that an expired device had been used.The customer responded that they were aware of this.The distributor followed up with a member of the care team on (b)(6) 2014, and was told they were aware of the expired product being used.They noticed it after the patient had already left.At this time they are watching the patient for any adverse reactions and will take necessary medical actions if that occurs.The distributor reported to the manufacturer, for now the customer is aware of the issue and they are handling the issue internally.There is no complaint from the customer, no injury is alleged.

Manufacturer Narrative

The device will not be returned since it was implanted.Based on reported information, integra has initiated an investigation.

• Brand Name: SILICONE MCP SZ 40
• Type of Device: SILICONE MCP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4379699
• MDR Text Key: 5284411
• Report Number: 1651501-2014-00056
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMCP-500-40-WW
• Device Lot Number: 113551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• 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