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

Catalog Number XXX-OPTIPLUG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

It was reported the pt experienced osteolysis around the optiplug.To date, no revision surgery has been planned.

Manufacturer Narrative

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

• Brand Name: OPTIPLUG- UNKNOWN SIZE
• Type of Device: OPTIPLUG
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear, suite b; irvine CA 92618
• Manufacturer (Section G): ISOTIS ORTHOBIOLOGICS, INC; 2 goodyear, suite b; irvine CA 92618
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6909362341
• MDR Report Key: 3769804
• MDR Text Key: 4375573
• Report Number: 2090010-2014-00022
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: NT
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• 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
• Date Manufacturer Received: 03/25/2014
• 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