MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X55 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482619555

Device Problem Material Separation (1562)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Device retained by hospital.

Event Description

It was reported that during final tightening, a xia serrato polyaxial screw the head detached from the screw shaft.No adverse consequences or medical intervention were reported.

Manufacturer Narrative

Visual, dimensional, functional and material 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.Per email correspondence with rep, metal fragments may have remained in the patient but no abnormality was found on the post-op x-ray.Torque wrench and anti torque key were used during final tightening.Torque wrench was reported to have fully inserted into the blocker.Rod was fully reduced before final tightening and surgeon did not appear to apply off axis or excessive force during final tightening or struggle during final tightening.It is unknown if the blocker was cross-threaded, if the angle at which surgery was being performed was difficult and if bottom of the tulip contacted bone.Surgical technique advises user to pay extra caution if the rod is not horizontally placed into the screw head, if the rod is high in the screw head or if an acute convex or concave bend is contoured into the rod.Since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: rod not horizontally placed into the screw head, over angulation on screw, application of excess cantilever force leading to tulip disengagement, etc.

Event Description

It was reported that during final tightening, a xia serrato polyaxial screw the head detached from the screw shaft.No adverse consequences or medical intervention were reported.

• Brand Name: 9.5X55 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 12057335
• MDR Text Key: 258050692
• Report Number: 3005525032-2021-00030
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351200
• UDI-Public: 07613327351200
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482619555
• Device Catalogue Number: 482619555
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1