MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC ORTHOBLAST-II PASTE

Catalog Number 02-2100-010

Device Problem Insufficient Information (3190)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Type  Injury  

Event Description

This is the second of 5 reports for this product problem (ref pt id: (b)(6)).It was reported that following an interbody fusion surgery there was infection, pus was found.The product is still implanted in the pt.It was reported the current opinion is the problem is not because of the orthoblast product.The infected pts are all elderly, over 70 years old, and have had combined orthopedic surgery (posterolateral fusion, interbody fusion with bone substitute).Add'l info has been requested.

Manufacturer Narrative

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

• Brand Name: ORTHOBLAST-II PASTE
• Type of Device: ORTHOBLAST
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4691839
• MDR Text Key: 16563574
• Report Number: 2090010-2015-00002
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K050642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02-2100-010
• Device Lot Number: 141899 (SUSPECTED LOT)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention