MAUDE Adverse Event Report: ALLOSOURCE, INC. ALLOFUSE CORTICAL CERVICAL SPACERS 4521 SERIES

Model Number 4521

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/12/2018

Event Type  Injury  

Event Description

After discharge, the physician discovered the fracture on a post op x-ray.The physician has used the 4521 series of cervical spacers for years.Over the last year he has now had 4 spacer fractures shown on post op x-ray checks.The 4 surgeries took place approximately over the last six months.He is not going to continue using them.He has applied bone stimulators to promote fusion and hopes that he does not have to re-operate.The physician stated there was a good chance that one of the patients will have a revision directly related to the spacer failure.Manufacturer response for allofuse cortical cervical spacers, (brand not provided) (per site reporter).The great lakes area manager for allosource stated in his recent email, "ideally, the conversation with [the physician] takes place with our medical director.The peer to peer dialog due to the severity of this situation calls for this escalated dialog." the area manager said that once he knows when the physician is available, he will facilitate.

• Brand Name: ALLOFUSE CORTICAL CERVICAL SPACERS 4521 SERIES
• Type of Device: CORTICAL CERVICAL SPACER
• Manufacturer (Section D): ALLOSOURCE, INC.; 6278 s troy circle; centennial CO 80111
• MDR Report Key: 8431753
• MDR Text Key: 139178918
• Report Number: 8431753
• Device Sequence Number: 1
• Product Code: MQV
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4521
• Device Catalogue Number: 45215007
• 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: 03/11/2019
• Event Location: Other
• Date Report to Manufacturer: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Required Intervention