MAUDE Adverse Event Report: LIFENET HEALTH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Lot Number 2213789-70000

Device Problem Nonstandard Device (1420)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Patient underwent left high tibial osteotomy, abrasion chondroplasty medial tibia and revision of acl reconstruction utilizing allograft material supplied by vendor.Vendor contacted surgeon 3 months later to report that allograft product used during this surgery may have failed several quality assurance tests to rule out presence of infectious diseases.Vendor reported low likelihood of disease transmission.Patient was notified and contacted vendor himself (patient is a physician) for further information.

• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): LIFENET HEALTH; 1864 concert dr.; virginia beach VA 23453
• MDR Report Key: 15635721
• MDR Text Key: 302058908
• Report Number: 15635721
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2213789-70000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Sex: Male