MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problem Unspecified Infection (1930)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent removal of bone graft and dental implant due to infection and non-integration seven days post-implantation.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.(b)(4).

• Brand Name: ENDOBON
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6491648
• MDR Text Key: 72778196
• Report Number: 3006946279-2017-00066
• Device Sequence Number: 1
• Product Code: LYC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK110449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: ROXLG50
• Device Lot Number: U0172286
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR