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

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products and therapy date detail of product: ref : og3040 - osseoguard tm resorbable collagen membrane 30 x 40 - (b)(4).According to the available data, the exact root cause of the event is likely the short delay between the implantation and the removal of the endobon, which did not enable the product to osseointegrate.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 has been reported that the product endobon xenograft did not integrate.Endobon placement performed the (b)(6) 2018 and the product removal performed on (b)(6) 2018.

• Brand Name: ENDOBON® XENOGRAFT GRANULES 0.5ML
• 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
• MDR Report Key: 8297677
• Report Number: 3006946279-2019-00086
• Device Sequence Number: 11251093
• Product Code: LYC
• UDI-Device Identifier: 03599870091258
• UDI-Public: 03599870091258
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: ROX05
• Device Lot Number: X0133342
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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