MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON® XENOGRAFT GRANULES 1.0ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.The necessary manufacturing history to review was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.A corrective action has been initiated to correct the issue.

Event Description

It was reported that patient underwent an oral bone grafting procedure.Subsequently, the bone graft was removed approximately three days post-implantation due to inflammation, non-integration and an abscess.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Udi: (b)(4).Examination of returned device found no evidence of product non-conformance.The review of manufacturing history shows that products were manufactured according to the pre-defined specifications.The sterilization certificate review shows that the sterilization was performed according to the applicable standards and the pre-defined specifications according to the available data, the exact root cause of the incident cannot be determined.There is no element which could jeopardize the conformity of the products.

• Brand Name: ENDOBON® XENOGRAFT GRANULES 1.0ML
• 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 ; 0334757591
• MDR Report Key: 5940923
• MDR Text Key: 54394471
• Report Number: 3006946279-2016-00300
• 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: foreign,user facility
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Expiration Date: 12/31/2016
• Device Model Number: N/A
• Device Catalogue Number: ROX10
• Device Lot Number: V044208A
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2015-03
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR