MAUDE Adverse Event Report: ENDOBON® XENOGRAFT GRANULES 0.5ML; BONE GRAFTING MATERIAL, SYNTHETIC

Model Number	ROX05
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/13/2018
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 review of the device manufacturing quality record indicates that 694 products endobon xenograft granules 0.5ml, reference (b)(4) batch u0153300 were manufactured on 12 november 2014.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Event or Problem Description
It was reported by the doctor the non integration of endobon.
Event or Problem Description
It was reported by the doctor non integration of endobon.Customer requests compensation.Additional information received on (b)(6) 2020 explain that curettage has been performed.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information and correction.The following section has been updated : b3, b4, b5, e1, e3, g4, h2, h6 and h10.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 non integration: - 10 complaints have been recorded on endobon xenograft granules 0.5ml, reference (b)(4), from 1 (b)(6) 2020.- 1 complaint has been recorded on endobon xenograft granules 0.5ml, reference (b)(4), batch u0153300.According to available data, the root cause of the event can¿t be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

• Brand Name: ENDOBON® XENOGRAFT GRANULES 0.5ML
• Common Device Name: BONE GRAFTING MATERIAL, SYNTHETIC
• MDR Report Key: 9472149
• Report Number: 3006946279-2019-00547
• Device Sequence Number: 11476027
• Product Code: LYC
• UDI-Device Identifier: 03599870091258
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: ROX05
• Device Catalogue Number: ROX05
• Device Lot Number: U0153300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 03/11/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention