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

Model Number 359100

Device Problems Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The company routinely issues communications regarding expiring product to sales personnel.This communication includes a list of serial numbers and locations for expiring product.This list is intended to be used by the sales representatives to ensure that expiring product is appropriately discarded.An expiring tissue field notification was emailed to sales personnel on 01/03/2020, which included the expiration date (04/04/2020), and location of the complaint graft.This graft had been at the surgical facility since 06/14/2018.The complainant received the expiring tissue field notification from the company on 1/03/2020.The graft was not appropriately discarded or returned to the company as instructed.

Event Description

The company received notification on 10/21/2020 from a sales distributor that a combination product graft had been implanted beyond the expiration date identified on the product package.There were no known patient complications associated with this report of an implanted expired device.

• 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 ; 4063880480
• MDR Report Key: 10872245
• MDR Text Key: 217707924
• Report Number: 3005031160-2020-00033
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 00849777003681
• UDI-Public: 00849777003681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

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 Expiration Date: 04/04/2020
• Device Model Number: 359100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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: 46 YR