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

Model Number	359100
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 10872245
• Report Number: 3005031160-2020-00033
• Device Sequence Number: 2862919
• Product Code: MBP
• UDI-Device Identifier: 00849777003681
• UDI-Public: 00849777003681
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: 359100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR