MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 50; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48146550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that a xia titanium 4.5 polyaxial screw disengaged less than 1 month post- operatively.
Event or Problem Description
A physician reported that a xia titanium 4.5 polyaxial screw disengaged less than 1 month post-operatively.Revision surgery has occurred.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and no visual abnormalities were found on the screw shaft/threads.There were heavy, asymmetrical rod indentations found on the head of the screw.A review of the device history was performed and there were no relevant manufacturing issues identified as all units met stryker specifications.A review of the complaint history records was performed and there were no similar complaints identified.Per surgical technique: the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.- loosening of spinal fixation implants can occur.Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.The patient had poor bone quality which is most likely contributed to the reported screw migration.It is possible that the "haloing" could have been caused by poor bone purchase due to poor bone quality.Heavy, asymmetrical rod indentations were also found on the screw heads of the two returned screws, further supporting the idea that the blocker was off loaded.As the rods were not seated horizontally into the tulip and the blockers were not torqued to the recommended 8nm, it is likely that the uneven force distribution created instability in the construct.This could have caused the rod to slip/migrate from the tulip.It is also possible that the instability in the construct may have also contributed to the migration of the s1 screws, along with the patients poor bone quality.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 50
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9586730
• Report Number: 0009617544-2020-00008
• Device Sequence Number: 14371067
• Product Code: NKB
• UDI-Device Identifier: 04546540450289
• UDI-Public: 04546540450289
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 48146550
• Device Catalogue Number: 48146550
• Device Lot Number: 186122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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