MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X80 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482618580

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

A company representative reported that, during implantation of a xia serrato polyaxial screw, the tulip disengaged from the shaft and the locking ring in the tulip deformed.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

Event Description

A company representative reported that, during implantation of a xia serrato polyaxial screw, the tulip disengaged from the shaft and the locking ring in the tulip deformed.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

Manufacturer Narrative

Visual inspection was performed and confirmed the tulip head to be disengaged from screw shank.The locking ring of the tulip is deformed and fractured.The bulb of the screw shank has a rod witness mark that trends towards one side of the bulb.Device history records were reviewed and no relevant manufacturing issues were identified.No similar complaints for the reported lot number were identified.Initial report states that two screws were inserted into each side of the iliac bone and connected with an offset connector.During final tightening of left side a sound was heard.The blocker was removed from the offset connector and the tulip of the associated screw was noted to be disengaged.According the the surgeon, the allowable angle of the screw head may have been exceeded.Follow-up with the field representative confirms that the screw was placed at a difficult angle, but that excessive force was not applied.From the xia 3 serrato surgical technique: note: the universal tightener is not to be used for final tightening.Use the anti-torque key and the torque wrench or audible torque wrench to final tighten the blockers.The anti-torque key must be used for final tightening.The anti-torque.Key performs two key functions: allows the torque wrench to align with the tightening axis.Helps to maximize the torque needed to lock the implant assembly.Place the anti-torque key over the screw head.Place the torque wrench or audible torque wrench through the anti-torque key into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.If using the audible torque wrench, the blocker is completely tightened to 12nm when the audible torque wrench clicks once.Caution: extra caution is advised in the following cases: the rod is not horizontally placed into the screw head.The rod is high in the screw head.An acute convex or concave bend is contoured into the rod.The locking ring fracture indicates excessive force may have been applied during final tightening or that the tulip was over angulated with respect to the screw shank.The location of the witness marks on the screw shank bulb indicates high angulation of tulip/rod with respect to shank body.The most likely cause of the reported event was determined to be due to high angulation of tulip and/or rod with respect to screw shank during final tightening.

• Brand Name: 8.5X80 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; SZ 2300
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13022268
• MDR Text Key: 284032273
• Report Number: 3005525032-2021-00045
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351187
• UDI-Public: 07613327351187
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482618580
• Device Catalogue Number: 482618580
• Device Lot Number: B83139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1