MAUDE Adverse Event Report: SYNTHES SYNTHES, INC. 1302 WRIGHTS LANE EAST WEST APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/01/2015

Event Type  Injury  

Event Description

A medtronic representative reported that on (b)(6) 2015, patient was affected in surgery.Dr.(b)(6) placed the screw successfully in a open cervical thoracic fusion (c1-t1).Navigation was done being used after the screw placement.Surgeon was preparing the anatomy for placing a non-medtronic (synthes) interbody implants and the patient started bleeding.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES SYNTHES, INC. 1302 WRIGHTS LANE EAST WEST
• MDR Report Key: 17530059
• MDR Text Key: 321140690
• Report Number: MW5136979
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR