MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC SYNPLUG SIZE 9; NONE

Catalog Number 804015

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Osteolysis (2377)

Event Date 11/19/2013

Event Type  Injury  

Event Description

This is the first of four reports concerning the same pt.This report concerns synplug size 9 product id 804015.It was reported: 'according to the received complaint, there was a perifocal osteolysis at the cement plug.The pt was also experiencing weakening of the bone and loosening of the prosthesis'.Additional information was requested by integra.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: SYNPLUG SIZE 9
• Type of Device: NONE
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3760815
• MDR Text Key: 4417963
• Report Number: 2090010-2014-00017
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2014

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: 804015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/09/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other