MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 10 DISTAL WW

Catalog Number MCP-100-10D-WW

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 12/03/2015

Event Type  Injury  

Event Description

It was reported the device was initially implanted (b)(6) 2013.At a later time the patient complained of increasing pain, discomfort and stiffness.It was reported a 2nd surgery was necessary to remove the implant.The revision surgery occurred on (b)(6) 2015.The distal part of the implant was removed and replaced by another one with a bigger size.

Manufacturer Narrative

Integra has completed their internal investigation on 22mar2016.The investigation included: methods: review of device history records.Review of complaint history.Results: no product/manufacturing issues were identified that would have caused or contributed to the event.A review of the complaint files found two complaints for an mcp implant being replaced for pain or stiffness.According to sales data, there have been (b)(4) procedures for the mcp system.This equates to an occurrence rate of (b)(4).Conclusion: a definitive root cause cannot be established, as the implant was not returned.Possible root causes may include incorrect sizing during the initial surgery, or injury to or other physiological impairment of the patient.

• Brand Name: MCP SZ. 10 DISTAL WW
• Type of Device: MCP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5449883
• MDR Text Key: 38641866
• Report Number: 1651501-2016-00014
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: P000057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCP-100-10D-WW
• Device Lot Number: 09-2106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention