MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48232480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained the device.
Event or Problem Description
It was reported that approximately 2.5 years post-operatively, after hearing a "pop", the patient presented with two fractured xia 3 rods.The patient was revised and their construct was extended.This record captures the second of the two rods.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed for this lot, as a valid lot number was not provided and could not be obtained.The device stg and ifu were reviewed and the following was found to be relevant: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/ nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.As the rod was not returned, a definite cause cannot be determined but based on available information, the cause of the event is likely multifactorial: patient's complex anatomy, inadequate construct per patient's anatomy and fatigue load on the construct over 2.5 years due to non-fusion.
Event or Problem Description
It was reported that approximately 2.5 years post-operatively, after hearing a "pop" and experiencing back pain, the patient presented with two fractured xia 3 rods.The patient was revised and their construct was extended.This record captures the second of the two rods.

• Brand Name: XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13022344
• Report Number: 0009617544-2021-00236
• Device Sequence Number: 14696663
• Product Code: NKB
• UDI-Device Identifier: 04546540560575
• UDI-Public: 04546540560575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/24/2022

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: 48232480
• Device Catalogue Number: 48232480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Unknown