MAUDE Adverse Event Report: XTANT MEDICAL OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY; BONE VOID FILLER

Model Number 359050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient had graft incorporation issues prior to the implantation of complaint device, suggesting there may have been some underlying comorbidities that could have hindered regeneration of bone at the surgical site.The complaint device reported to have insufficient graft incorporation is subject to regular osteoinductivity testing, which indicates bone growth potential.The revision acl reconstruction procedure in which the complaint device was implanted was successfully completed.

Event Description

The company received notification on 8/02/2021 of a product complaint regarding a combination device that was reported to not function as intended for bone growth.It was reported that during a revision acl reconstruction procedure on an unknown date, the physician assessed there was insufficient graft incorporation.The information provided on the clinical course of treatment was unclear.Repeated attempts for clarification were made without any additional information provided.The most recent revision acl reconstruction procedure was successfully completed without any known patient complications.

Event Description

Additional information was provided on september 7, 2021 which identified the complaint graft was not osteoselect demineralized bone matrix putty as initially reported.The complaint graft was manufactured by another company.The graft used during the procedure was not manufactured by the company, therefore we are unable to investigate or comment on the root cause.This follow-up report is associated with mfr 3005031160-2021-00017.

• Brand Name: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12404252
• MDR Text Key: 269253301
• Report Number: 3005031160-2021-00017
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): Y
• PMA/PMN Number: K130498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 359050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR