MAUDE Adverse Event Report: AMENDIA SAVANNAH-T; PEDICLE SCREW SPINAL SYSTEM

Model Number 10-21-6545-1

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

This failure occurred over 3 years post-op; fusion likely occurred, but failure led to additional revision surgery which would classify this event as a serious injury per fda draft guidance.Date of initial surgery listed as (b)(6) 2013, however please note the exact day in 2013 is not known; esubmitter will not allow to enter only the year of the event, therefore (b)(6) was entered.

Event Description

Screw fracture requiring revision surgery.

• Brand Name: SAVANNAH-T
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer (Section G): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer Contact: bruce hooper ; 1755 west oak parkway; marietta, GA 30062 ; 8777553329
• MDR Report Key: 6208764
• MDR Text Key: 63405322
• Report Number: 1067095-2016-00032
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2016

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: Physician
• Device Model Number: 10-21-6545-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention