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.

• Brand Name: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 12403674
• MDR Text Key: 277945749
• Report Number: 3005031160-2021-00016
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K130498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: 359050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 19 YR