MAUDE Adverse Event Report: GENESYS SPINE APACHE; IBFD

Model Number GP-11

Device Problems Failure To Adhere Or Bond (1031); Expulsion (2933)

Patient Problems First Use Syndrome (2239); Inadequate Pain Relief (2388)

Event Date 03/19/2014

Event Type  Injury  

Event Description

Patient was 3 weeks post op from having a posterior lumbar interbody fusion complaining of back pain.Top level of a 4 level fusion retropulsed out of disc space.Surgeon performed revision surgery to explant peek cage.No subsequent complications were reported.

Manufacturer Narrative

The device was requested but was not returned.Cage was discarded after surgery removed it on (b)(6) 2014.Due to high stress at the thoracolumbar junction, the cage retropulsed posteriorly out of the disc space.

• Brand Name: APACHE
• Type of Device: IBFD
• Manufacturer (Section D): GENESYS SPINE; austin TX
• Manufacturer Contact: dave lamb ; 1250 south capital of texas hwy; building 3, suite 600; austin, TX 78746 ; 5123817094
• MDR Report Key: 3861901
• MDR Text Key: 17611290
• Report Number: 3008455034-2014-00002
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014

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: Health Professional
• Device Model Number: GP-11
• Device Lot Number: 10757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2013
• 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
• Treatment: PEDICLE SCREWS,; CROSSLINK FOR FIXATION; RODS,; SET-CAPS, AND
• Patient Outcome(s): Hospitalization; Required Intervention