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

Catalog Number	640-1005
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SPINAL SCREW SYSTEM
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n; suite 600; st. paul MN 55128 5455
• MDR Report Key: 5798135
• Report Number: 2135156-2016-00003
• Device Sequence Number: 13636643
• Product Code: NKB
• UDI-Device Identifier: M7406401005
• UDI-Public: M7406401005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 640-1005
• Device Lot Number: S15609
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2016
• Initial Report FDA Received Date: 07/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR