MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48289999
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented to the hospital with "complaints".Upon review of xray, it was observed that two xia 3 titanium blockers had come loose from the screw head.Revision surgery has been performed.This report captures the second of two blockers.
Additional Manufacturer Narrative
Corrected data: b.5.Has been updated to reflect that only one blocker was reported to have migrated.Upon additional review of reported information and the received device, it has been determined that only one blocker was reported to have migrated initially.No issue related to the reported event was found with this product.This blocker does not show signs of migration as there is no chattering and 2 rod indentations present from final tightening.
Event or Problem Description
It was reported that a patient presented to the hospital with "complaints".Upon review of xray, it was observed that two xia 3 titanium blockers had come loose from the screw head.Revision surgery has been performed.Upon additional review of reported information and the received device, it has been determined that only one blocker migrated.The reportable blocker has been captured in 3005525032-2020-00035.There is no event associated with the blocker captured in this mdr.

• Brand Name: XIA 3 TITANIUM BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10384493
• Report Number: 3005525032-2020-00036
• Device Sequence Number: 11309222
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• Combination Product (Y/N): N
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 48289999
• Device Catalogue Number: 48230000
• Device Lot Number: 5AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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