MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE(R) INJECTABLE BONE GRAFT; BIOLOGIC COMPONENT

Catalog Number 87SR-0404

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.

Event Description

Allegedly, the patient has not been revised.Dr.Reports an inflammatory reaction at site of implantation.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: PRO-DENSE(R) INJECTABLE BONE GRAFT
• Type of Device: BIOLOGIC COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901451-631
• MDR Report Key: 5886598
• MDR Text Key: 52449646
• Report Number: 1043534-2016-00078
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 87SR-0404
• Device Lot Number: 1574022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/20/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1