MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC OPTIPLUG - UNK SIZE

Catalog Number XXX-OPTIPLUG

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

"a recent complaint concerning synplug and osteolysis resulted in a health hazard eval.This eval identified osteolysis as meeting the criteria of mdr reportable.A retrospective review has been conducted of our complaint management system resulting in the filing of this mdr".

Manufacturer Narrative

An investigation has been initiated based on the reported info.

• Brand Name: OPTIPLUG - UNK SIZE
• Type of Device: OPTIPLUG
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer Contact: vivian nelson ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 3687562
• MDR Text Key: 4298607
• Report Number: 2090010-2014-00007
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,User Facility,Distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/27/2013

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-OPTIPLUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/12/2014
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1