MAUDE Adverse Event Report: SPINEOLOGY INC. FORTRESS PEDICULAR FIXATION SYSTEM; SPINAL SCREW SYSTEM

Catalog Number 640-1005

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

All four set screws and two (2) rods were returned to spineology.Microscopic evaluation of the returned set screws and rods was inconclusive.Note: spineology filed two (2) mdrs for this event; one for each of the cephalad set screws that were reported to have separated from the spinal construct.The two (2) mdr #s are: 2135156-2016-00003 and 2135156-2016-00004.

Event Description

The physician performed an l4-l5 posterior fusion surgical procedure on (b)(6) 2016.Approximately 4 weeks following the surgical procedure, during a routine follow-up visit radiographic images revealed that both of the cephalad set screws had become loose and separated from the tulip heads of the cortical screws.The patient was returned to surgery on (b)(6) 2016 at which time the two caudal set screws were assessed and determined to be tight.The spinal construct was diassembled and the cortical screws were manually manipulated and determined to be tight with no evidence of loosening.The spinal construct was reassembled using the previously implanted cortical screws, two new rods, and four new set screws.On (b)(6) 2016, the patient was reported to be "doing very well".

• Brand Name: FORTRESS PEDICULAR FIXATION SYSTEM
• Type of Device: SPINAL SCREW SYSTEM
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n; suite 600; st. paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY INC.; 7800 3rd street n; suite 600; st. paul MN 55128 5455
• Manufacturer Contact: jacqueline hauge ; 7800 3rd street n.; suite 600; st. paul, MN 55128-5455 ; 6512568500
• MDR Report Key: 5798135
• MDR Text Key: 49648592
• Report Number: 2135156-2016-00003
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: M7406401005
• UDI-Public: M7406401005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 640-1005
• Device Lot Number: S15609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• 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): Other
• Patient Age: 55 YR