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

Model Number ROX05

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/13/2018

Event Type  Injury  

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 Description

It was reported by the doctor the non integration of endobon.

Event 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.

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
• Type of Device: BONE GRAFTING MATERIAL, SYNTHETIC
• MDR Report Key: 9472149
• MDR Text Key: 171977684
• Report Number: 3006946279-2019-00547
• Device Sequence Number: 1
• Product Code: LYC
• UDI-Device Identifier: 03599870091258
• UDI-Public: (01)03599870091258
• Combination Product (y/n): N
• PMA/PMN Number: K110449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention