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

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inflammation (1932); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: ENDOBON XENOGRAFT GRANULATES LARGE 5 ML
• Common Device Name: 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
• Report Number: 3006946279-2023-00060
• Device Sequence Number: 19818751
• Product Code: LYC
• UDI-Device Identifier: 03599870097571
• UDI-Public: (01)03599870097571(17)230531(10)AB0132350
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose