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

Model Number 27800218

Device Problem Component Missing (2306)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

The manufacturer was made aware of an alleged medical device graft complaint on 10/05/2022.It was reported that a medical device graft distributed was identified as having empty graft packaging at an end user facility.

Manufacturer Narrative

A photo was provided which showed implant stickers, product instructions for use, opened foil pouch packaging, and the medical device graft carton.The transplant utilization record and medical device graft were not included.The photo provided showed the manufacturer seal of the foil pouch packaging had been breached and the xtant seal was present and unopened.There was no graft present in the opened packaging.A review of the processing chart was unremarkable.The complaint medical device graft met all required specifications and passed all in-process and release inspections prior to distribution.The manufacturer completes a 100% volume verification prior to being released to distributable inventory, to ensure the appropriate volume is present in the graft package.The root cause of this complaint cannot be reliably determined.There have not been any other complaints of similar nature in the past 12 months.The manufacturer considers this complaint to be an isolated event that cannot be confirmed.The manufacturer will continue to monitor the product family for complaints from the field.

• 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: 15721566
• MDR Text Key: 306920181
• Report Number: 3005031160-2022-00030
• Device Sequence Number: 1
• Product Code: MBP
• UDI-Device Identifier: 00849777008761
• UDI-Public: 00849777008761
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27800218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other