MAUDE Adverse Event Report: ALLOSOURCE ALLOFUSE PLUS PASTE; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number 90238008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

Patient health status not given.Report of infection only.Updates will be given as/if more information is obtained from the customer.

Event Description

Customer contacted our vp of international sales via email and stated that the patient is experiencing infection and the surgeon/lifemed wanted to ensure that the products were all sterilized.As of 02/22/2024 no further information has been given regarding patient status or infection type.

• Brand Name: ALLOFUSE PLUS PASTE
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): ALLOSOURCE; 6278 south troy circle; centennial CO 80111
• Manufacturer Contact: theresa lumsden ; 6278 south troy circle; centennial, CO 80111 ; 7208734856
• MDR Report Key: 18763401
• MDR Text Key: 336053226
• Report Number: 3000215346-2024-00001
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K103036
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Catalogue Number: 90238008
• Device Lot Number: 222619-6568
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2022
• 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 Age: 24 YR
• Patient Sex: Male