MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 2.0ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 04/28/2015

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided: device info - lot number and expiration ni.Manufacture date ¿ ni.

Event Description

It was reported that patient underwent an oral bone grafting procedure.Subsequently, the bone graft was removed approximately ten days post-implantation due to infection, discomfort and non-integration.The patient was also prescribed medications due to the event.

• Brand Name: ENDOBON® XENOGRAFT GRANULES LARGE PARTICLE 2.0ML
• Type of Device: BONE GRAFTING MATERIAL, SYNTHETIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: elisabeth plane ; plateau de lautagne bp75; valence cedex 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 5800059
• MDR Text Key: 49740015
• Report Number: 3006946279-2016-00234
• Device Sequence Number: 1
• Product Code: LYC
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: PK110449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/15/2016

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?: Yes
• Device Operator: Dentist
• Device Model Number: N/A
• Device Catalogue Number: ROXLG20
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/16/2016
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention