MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY; BONE VOID FILLER

Model Number DBM001

Device Problem Expiration Date Error (2528)

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

Event Date 01/20/2024

Event Type  malfunction  

Manufacturer Narrative

The sterile-packed product had an expiration date of 11/08/2023, which was purchased and distributed from the manufacturer on 7/16/2021.Final product labeling affixed to the product carton and graft packaging clearly identifies the expiration date assigned to the product in the yyyy-mm-dd labeling format with a date format legend for clarity and ease of identifying the product expiration date.The precautions section of the ifu distributed with the product states, "the allograft should not be used if the expiration date has been surpassed, the container in which the product is stored is damaged, the product is not labeled, or the required storage conditions have not been maintained." the root cause of this event is a lack of sterile product expiration date management at the surgical facility where the product was implanted.There has been one other event of sterile-packed products implanted beyond the expiration date in the past 12 months for labeling activites performed by the manufacturer.The manufacturer will continue to monitor the field for communications of sterile-packed product implanted beyond the expiration date identified on the product labeling.

Event Description

The manufacturer was made aware of an event on 1/24/2024, in which it was reported a sterile-packed product was implanted on (b)(6) 2024 beyond the expiration date identified on the product label.There were no reported patient complications or delay in treatment associated with this event.

• Brand Name: OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 18768795
• MDR Text Key: 336635460
• Report Number: 3005031160-2024-00003
• Device Sequence Number: 1
• Product Code: MBP
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: DBM001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2018
• 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: 20 YR
• Patient Sex: Male