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

Model Number	N/A
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the sterilization certificate indicates that the products were sterilized according to the specification.The review of the raw material certificate shows no non conformity or deviation.The label of the product is stuck on the zper and confirms the expiration date.Complaint history : a complaint extract was done regarding medical : infection and non integration: 12 complaints (12 products), this one included, have been recorded on endobon® xenograft granules 0.5ml, reference rox05, from 01 jan 2018 to 18 aug 2021.1 complaint (1 product), this one included, has been recorded on endobon® xenograft granules 0.5ml, reference rox05, batch y0098304.A complaint extract was done regarding medical : expired product implanted.1 complaint (1 product), this one included, has been recorded on endobon® xenograft granules 0.5ml, reference rox05, from 01 jan 2018 to 27 aug 2021.1 complaint (1 product), this one included, has been recorded on endobon® xenograft granules 0.5ml, reference rox05, batch y0098304.Investigation results concluded that the reported event was due to user error (the product has been used in spite of the expiration date passed).A summary of the investigation was sent to the complainant conveying proper use of the device.There is no evidence that the event is related to the product.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 patient had a loss of integration and infection with pain and inflammation after a endobon xenograft implantation.Doctor performed reconstruction.

• Brand Name: ENDOBON® XENOGRAFT GRANULES 0.5ML
• Common Device Name: BONE MATRIX IMPLANT, ANIMAL-DERIVED, NON-ABSORBABLE
• MDR Report Key: 12376477
• Report Number: 3006946279-2021-00139
• Device Sequence Number: 4536524
• Product Code: LYC
• UDI-Device Identifier: 03599870091258
• UDI-Public: 03599870091258
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: ROX05
• Device Lot Number: Y0098304
• 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: 08/17/2021
• Initial Report FDA Received Date: 08/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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: Required Intervention
• Patient Age: 56 YR