MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. ENDOBON XENOGRAFT GRANULATES LARGE 8 ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.The device history record has been reviewed.No discrepancies were found.With the available information, the exact root cause of the event could not 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
The doctor reported an allergic reaction to endobon product.The doctor reported that sinus lift in tooth position 16 was performed on (b)(6) 2018.7 days later, after medication treatment had already been finished, the patient developed an allergic reaction with exanthem and itch.The symptoms appeared in particular in the face, on the neck and cleavage, not in the patient mouth.Cortisone treatment was performed.As patient's condition did not improve, doctor removed completely the endobon product on (b)(6) 2018.Information on patient health status received the (b)(6) 2018 confirmed that the patient is well and the allergy has gone.2 endobon products were involved in this event.The investigation for the second endobon product is performed in the report for (b)(4).

• Brand Name: ENDOBON XENOGRAFT GRANULATES LARGE 8 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
• MDR Report Key: 8297519
• Report Number: 3006946279-2019-00085
• Device Sequence Number: 1953449
• Product Code: LYC
• UDI-Device Identifier: 03599870097588
• UDI-Public: 03599870097588
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110449
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: ROXLG80
• Device Lot Number: X0273004
• 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: 05/25/2018
• 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: Required Intervention
• Patient Age: 56 YR