MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON XENOGRAFT GRANULATES LARGE 5 ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number N/A

Device Problem Failure to Osseointegrate (1863)

Patient Problems Inflammation (1932); Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

It was reported that the implant failed to heal after sinus lift procedure.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2 foreign austria.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned product from the same batch show no specific issue.Products are intact.No issue found.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ENDOBON XENOGRAFT GRANULATES LARGE 5 ML
• 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: 17150576
• MDR Text Key: 317452397
• Report Number: 3006946279-2023-00060
• Device Sequence Number: 1
• Product Code: LYC
• UDI-Device Identifier: 03599870097571
• UDI-Public: (01)03599870097571(17)230531(10)AB0132350
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K110449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: ROXLG50
• Device Lot Number: AB0132350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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): Other
• Patient Sex: Prefer Not To Disclose