MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON XENOGRAFT GRANULES 0.5ML; BONE GRAFTING MATERIAL

Model Number N/A

Device Problem Osseointegration Problem (3003)

Patient Problem Pain (1994)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).

Event Description

Patient experienced dental bone graft infection and non-integration approximately four months post-implantation.Patient was prescribed antibiotics.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ENDOBON XENOGRAFT GRANULES 0.5ML
• Type of Device: BONE GRAFTING MATERIAL
• 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: 6216311
• MDR Text Key: 63663905
• Report Number: 3006946279-2016-00473
• Device Sequence Number: 1
• Product Code: LYC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK980679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: ROX05
• Device Lot Number: V0092327
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR