MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48130000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained.
Event or Problem Description
It was reported that four xia titanium 4.5 blockers disengaged from their respective screws three years post-operatively and were discovered via x-ray.Revision surgery has occurred.This record represents blocker 1 of 4.
Event or Problem Description
It was reported that four xia titanium 4.5 blockers disengaged from their respective screws three years post-operatively and were discovered via x-ray.Revision surgery has occurred.This record represents blocker 1 of 4.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, post-op x-rays were provided showing 2 rods and 4 blockers migrated out of the screw.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was reported that during implantation, screws did not give enough polyaxiality and the surgeon needed to compresses.Surgeon over tightened and feels this was an issue with over compressing.Per the surgical technique, once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is done by utilizing the anti-torque key and the torque wrench.The torque wrench indicates the appropriate torque that has to be applied to the implant for final tightening.Line up the arrow to the line in order to achieve this final tightening torque of 8 nm.During final tightening, 8 nm must not be exceeded.It was also reported that the patient did not fuse.Per the surgical technique, inappropriate or improper surgical placement of this device may cause distraction or stress shielding of the graft or fusion mass.This may contribute to failure of an adequate fusion mass to form.The root cause of the reported event is multifactorial and includes: overtightening of the blockers; surgeon applied too much force to the spine during compression; pseudarthrosis.

• Brand Name: XIA TITANIUM 4.5 BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9936077
• Report Number: 0009617544-2020-00059
• Device Sequence Number: 14077753
• Product Code: NKB
• UDI-Device Identifier: 04546540448897
• UDI-Public: 04546540448897
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48130000
• Device Catalogue Number: 48130000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: Required Intervention