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

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problem Inflammation (1932)

Event Date 02/06/2016

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The necessary manufacturing history was not provided for review.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: date implanted - ni.Corrective action was initiated to address the reported issue.Product requested, but not yet returned.

Event Description

It was reported that patient underwent an oral bone grafting procedure.Subsequently, the patient experienced inflammation, non-integration and graft loss which required intervention to clean the surgical site.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Event Description

It was reported that patient underwent an oral bone grafting procedure.The patient experienced inflammation, non-integration and graft loss 4 months post-implantation, which required intervention to clean the surgical site 1 year post-implantation.

• Brand Name: ENDOBON XENOGRAFT GRANULES
• 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 ; 0334757591
• MDR Report Key: 5746441
• MDR Text Key: 48093812
• Report Number: 3006946279-2016-00200
• Device Sequence Number: 1
• Product Code: LYC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK110449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: ROXLG50
• Device Lot Number: U0091189
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FR 2015-03
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR