MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482315535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a spinal surgery on (b)(6) 2015.After making the recovery as established by the doctor, patient continued in pain.On (b)(6) 2016 the surgeon requested a computed tomography where it was evident that the placed implant is broken.This resulted in a revision surgery which was performed on (b)(6) 2016.
Additional Manufacturer Narrative
Method: risk assessment, x-rays.Results: the reported event was confirmed via x-ray review.Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The screws were initially implanted in (b)(6) 2015 and in (b)(6) 2016 it was confirmed that the screws fractured.The ifu states that "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone." conclusion: as the device was not returned, a definite root cause cannot be determined.If the device or more information becomes available, this investigation will be reopened and updated.
Event or Problem Description
It was reported that a patient underwent a spinal surgery on (b)(6) 2015.After making the recovery as established by the doctor, patient continued in pain.On (b)(6) 2016 the surgeon requested a computed tomography where it was evident that the placed implant is broken.This resulted in a revision surgery which was performed on (b)(6) 2016.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7649050
• Report Number: 3005525032-2018-00044
• Device Sequence Number: 1651818
• Product Code: NKB
• UDI-Device Identifier: 04546540562036
• UDI-Public: (01)04546540562036
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2018

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: No Information
• Device Model Number: 482315535
• Device Catalogue Number: 482315535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/23/2018
• 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
• Patient Age: 49 YR