MAUDE Adverse Event Report: STRYKER SPINE-US XIA ROD DIA. 6 X 480; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	4107038
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital kept the device.
Event or Problem Description
It was reported that a macc connector fractured post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Section b5 was corrected from "it was reported that a macc connector fractured post-operatively.Revision surgery was performed." to "it was reported that on (b)(6) 2018, the surgeon performed a spinal lesion removal and bone grafting combined with a titanium mesh internal fixation surgery.On (b)(6) 2018 an initial revision surgery was conducted to address the titanium mesh which is a non stryker product.Then on (b)(6) 2019 a xia rod fractured and a second revision surgery was performed." d1 through d4 was corrected to reflect the correct device information from a macc connector to a xia rod.D6 was corrected from (b)(6) 2019 to (b)(6) 2019 to reflect the correct revision surgery date.
Event or Problem Description
It was reported that on (b)(6) 2018, the surgeon performed a spinal lesion removal and bone grafting combined with a titanium mesh internal fixation surgery.On (b)(6) 2018 an initial revision surgery was conducted to address the titanium mesh which is a non stryker product.Then on (b)(6) 2019 a xia rod fractured and a second revision surgery was performed.
Event or Problem Description
It was reported that on (b)(6) 2018, the surgeon performed a spinal lesion removal and bone grafting combined with a titanium mesh internal fixation surgery.On (b)(6) 2018 an initial revision surgery was conducted to address the titanium mesh which is a non stryker product.Then on (b)(6) 2019 a xia rod fractured and a second revision surgery was performed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for lot # awm.No relevant manufacturing issues or similar complaints were identified as all units met stryker specifications.From the xia instructions for use: 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, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.As the rod was not returned, a definite root cause cannot be determined.However, based on the length of implantation (1 year), fatigue fracture may have occurred.

• Brand Name: XIA ROD DIA. 6 X 480
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9521681
• Report Number: 0009617544-2019-00147
• Device Sequence Number: 535515
• Product Code: NKB
• UDI-Device Identifier: 04546540216687
• UDI-Public: 04546540216687
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2020

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: 4107038
• Device Catalogue Number: 03802480
• Device Lot Number: AWM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 02/21/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/13/2020; 03/19/2020
• 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: 76 YR