MAUDE Adverse Event Report: BACTERIN INTERNATIONAL, INC. OSTEOWRAP; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number B080038-211

Device Problems Unsealed Device Packaging (1444); Improper or Incorrect Procedure or Method (2017); Inaccurate Information (4051)

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

Event Date 04/04/2013

Event Type  malfunction  

Event Description

The patient entered the operating room (or) for surgery.The representative came, bringing the allograft packages, removed the allograft implants from the box and gave the contents to the or registered nurse (rn).No problem with sterile packaging.Implants were used.Later when filling out the patient human tissue implant record it was discovered that the bacterin paperwork had already been filled in with another patient's information.Apparently the tissue tracking form had been filled out by a sales representative but the tissue had not been implanted.The representative notified the company who told him that it is not uncommon to receive unused product and return it to their shelves for redistribution.The box had no seal, and was quite worn.We were concerned that we received a previously opened product, no seal, with another patient's information on the card.

• Brand Name: OSTEOWRAP
• Type of Device: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): BACTERIN INTERNATIONAL, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 16663195
• MDR Text Key: 312529509
• Report Number: 16663195
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2013

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 Model Number: B080038-211
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2013
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White