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

Catalog Number	640-6540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because the complaint reported that four (4) pedicle screws were broken; a separate mdr has been filed for each of the broken screws.The mdr numbers associated with this event are as follows: 2135156-2016-00005, 2135156-2016-00006, 2135156-2016-00007, 2135156-2016-00008.Device not returned.
Event or Problem Description
The patient underwent a 2-level spinal surgical procedure on (b)(6) 2014 with placement of six (6) fortress pedicle screws, six (6) fortress set screws, and two (2) fortress rods.An unspecified anterior interbody fusion was also placed.At an unspecified time following the initial implant procedure, the patient suffered a fall for unknown reasons and reported "popping and pain".Ct imaging revealed that four of the six pedicle screws sustained screw shank fractures.The imaging also revealed that the interbody device appeared to be "very well fused".On (b)(6) 2016, the patient returned to surgery at which time all fortress devices were explanted.The distal shank ends of the four broken pedicle screws were unable to be retrieved.Spineology made multiple attempts to obtain additional information regarding this event; however, all attempts were unsuccessful.

• Brand Name: FORTRESS PEDICULAR FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n; suite 6500; st. paul MN 55128 5455
• MDR Report Key: 5936486
• Report Number: 2135156-2016-00005
• Device Sequence Number: 18920517
• Product Code: NKB
• UDI-Device Identifier: M7406406540
• UDI-Public: M7406406540
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2016

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
• Operator of Device: Physician
• Device Expiration Date: 06/10/2017
• Device Catalogue Number: 640-6540
• Device Lot Number: S14200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2016
• Initial Report FDA Received Date: 09/08/2016
• 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