MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS, INC SYNPLUG SIZE 14

Catalog Number 804020

Device Problem Nonstandard Device (1420)

Patient Problem Osteolysis (2377)

Event Date 07/17/2014

Event Type  Other  

Event Description

It was reported "following the field safety notice (fsn) date of march, we want to report a case of osteolysis on a patient who had synplug implanted.It was a patient of (b)(6) years old who had surgery in (b)(6) 2002.During a follow-up visit, on (b)(6) 2014, an osteolysis was seen near the synplug implantation of the x-ray.There is no other known cause to explain this phenomena.The patient is asymptomatic.X ray and eventually scanner are planned in 6 months for this patient." additional information was provided on (b)(6) 2014.Surgery date: (b)(6) 2002.

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 14
• Type of Device: NA
• Manufacturer (Section D): ISOTIS ORTHOBIOLOGICS, INC; irvine CA 92618
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4129742
• MDR Text Key: 17696877
• Report Number: 2090010-2014-00024
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 804020
• Device Lot Number: 111.138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• 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
• Treatment: PALACOS GENTALLINE; TOTAL CONCEPT PROSTHESIS ALUMINA POLYETHYLENE
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 78