MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	03828645
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that two xia deformity long arm monoaxial screws fractured post-operatively.Radiography showed that the two screws had fractured and that the patient had fused.Revision surgery was performed and the two screws were successfully removed.This report represents the first of the two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, photos were provided showing the screws fractured at the threaded shaft section.Device and complaint history records were reviewed and no relevant manufacturing issues were identified as all units met stryker specifications.From the xia ifu: 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.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Based on the length of implantation and the fact that the patient fused, the most likely root cause is due to fatigue fracture.
Event or Problem Description
It was reported that two xia deformity long arm monoaxial screws fractured post-operatively.Radiography showed that the two screws had fractured and that the patient had fused.Revision surgery was performed and the two screws were successfully removed.This report represents the first of the two screws.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM MONOAXIAL SCREW 6.5 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10136034
• Report Number: 0009617544-2020-00082
• Device Sequence Number: 19629352
• Product Code: NKB
• UDI-Device Identifier: 07613154407644
• UDI-Public: 07613154407644
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 03828645
• Device Catalogue Number: 03828645
• Device Lot Number: 172741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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
• Patient Age: 24 YR