MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 50; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48145550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the physician that the screw was broken post-operatively.Patient was revised to replace the screw.
Event or Problem Description
It was reported by the physician that the screw was broken post-operatively.Patient was revised to remove and replace the screw.The broken shaft of the screw remains implanted in the patient.
Additional Manufacturer Narrative
Visual inspection confirmed that threading of returned screw was fractured.Functional inspection could not be performed because the device was confirmed to be damaged during visual inspection.A material analysis was performed and the polyaxial screw was found to have fractured in fatigue due to an applied unidirectional force.The elemental constituents were as specified on the print.No material or manufacturing defects were found.Device and complaint history records were reviewed and no relevant issues or complaints were identified.The instructions for use (ifu) also provide indications for this product.The following excerpts show examples of this: "once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants should be taken into consideration by the surgeon at the time of the choice of the implant, during implantation as well as in the post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidate.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.Adverse effects may necessitate reoperation or revision." root cause of reported event could not be determined conclusively but based on material analysis and risk table, most likely due to fatigue on construct- excessive post-op activity by patient/ surgeon applied too much torque to tighten blockers or poor fixation construct.
Event or Problem Description
It was reported by the physician that the screw was broken post-operatively.Patient was revised to remove and replace the screw.The broken shaft of the screw remains implanted in the patient.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 50
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8768052
• Report Number: 0009617544-2019-00086
• Device Sequence Number: 1668596
• Product Code: NKB
• UDI-Device Identifier: 04546540450203
• UDI-Public: 04546540450203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/22/2019

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 Catalogue Number: 48145550
• Device Lot Number: 062278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 09/23/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 07/22/2019; 10/22/2019
• 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