MAUDE Adverse Event Report: ENDOBON XENOGRAFT GRANULES 0.5ML; BONE MATRIX IMPLANT, ANIMAL-DERIVED, NON-BIOABSORBABLE

Model Number	ROX05
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported loss of integration for endobon graft placed at tooth site 24, around 5 months after implantation.Endobon graft has been removed.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The product analysis can't be performed as the product was not returned the device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding loss of integration: 1 complaint (1 product), this one included, has been recorded on endobon xenograft granules 0.5ml, reference rox05, from 1 january 2017 to 12 august 2020 1 complaint (1 product), this one included, has been recorded on endobon xenograft granules 0.5ml, reference rox05, batch z0124268.According to available data, root cause of the event was unable to be determined.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.
Event or Problem Description
It was reported loss of integration for endobon graft placed at tooth site 24, around 5 months after implantation.Endobon graft has been removed.No additional patient consequences were reported.

• Brand Name: ENDOBON XENOGRAFT GRANULES 0.5ML
• Common Device Name: BONE MATRIX IMPLANT, ANIMAL-DERIVED, NON-BIOABSORBABLE
• MDR Report Key: 10232369
• Report Number: 3006946279-2020-00127
• Device Sequence Number: 2426200
• Product Code: LYC
• UDI-Device Identifier: 03599870091258
• UDI-Public: 03599870091258
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: ROX05
• Device Catalogue Number: ROX05
• Device Lot Number: Z0124268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/24/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization