MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482616540

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Device implanted in patient.

Event Description

It was reported that xia serrato screw broke the pedicle upon implantation intra-operatively.No adverse consequences, or medical intervention were reported. the procedure was completed successfully with an unknown surgical delay.

Manufacturer Narrative

B1 has been updated from "adverse event and product problem" to "adverse event" h6, device code, has been updated from "fracture" to " adverse event without identified device or use problem".Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Device sgt and ifu were reviewed: "for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body screw insertion: with the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended.Implant selection and use the choice of proper shape, size and design of the implant for each patient is crucial to the success of the surgery.The surgeon is responsible for this choice which depends on each patient.Adverse effects.Intraoperative fissure, fracture, or perforation of the spine can occur due to implantation of the components.Postoperative fracture of bone graft, the intervertebral body, pedicle, and/or sacrum above and/or below the level of surgery can occur due to trauma, the presence of defects, or poor bone stock." for larger diameter screws, there is more torque applied at the upper part of the screw due to the cancellous cortical thread design combined with a dual lead.Under-tapping may cause the screw to become bound in the bone, and with the excess torque applied to drive the screw down, may cause the pedicle to fracture.Possible root causes include lack of tapping, under tapping, difficult angle, and/or excess torque applied.However, as no additional information was received from the field or and the product is still implanted in the patient, the root cause could not be determined conclusively.

Event Description

It was reported that during intra-operative implant insertion a xia serrato screw broke the patient's pedicle.The screw was left implanted in the patient.No adverse consequences, or medical intervention were reported.The surgeon notes that the procedure was completed successfully with an unknown surgical delay.

• Brand Name: 6.5X40 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 12094542
• MDR Text Key: 259229325
• Report Number: 3005525032-2021-00032
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351958
• UDI-Public: 07613327351958
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482616540
• Device Catalogue Number: 482616540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other