MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X70 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482617570

Device Problems Material Separation (1562); Material Deformation (2976)

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

Event Date 01/28/2021

Event Type  malfunction  

Event Description

It was reported that during final tightening of a xia serrato polyaxial screw, the head of the screw 'opened' intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.

Manufacturer Narrative

Following investigation completion, h6 (device code) was updated from 'material separation' to 'material deformation'.Visual inspection confirmed that there is deformation on the top 2-3 threads on both sides of the tulip.Shank bulb deformations from offset connector indicates multiple attempts of tightening.During functional it was difficult to thread on screw onto driver.It was also difficult to insert a blocker onto the screw head.Device and complaint history records were reviewed for this lot, no relevant manufauring issues or similar complaints were identified.From the serrato surgical technique: 'blocker positioning serrato uses the xia buttress thread blocker closure mechanism.Assemble the blocker to the universal tightener for insertion.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'.Most likely cause of reported event is due to misalignment of blocker in tulip head during provisional and/or final tightening.Multiple tightening passes may have also contributed to reported event.Improper positioning or torque of blocker can cause the reported and observed tulip thread deformation.

Event Description

It was reported that during final tightening of a xia serrato polyaxial screw, the head of the screw 'opened' intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences or medical intervention were reported.

• Brand Name: 7.5X70 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11366750
• MDR Text Key: 233329885
• Report Number: 3005525032-2021-00006
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327352672
• UDI-Public: 07613327352672
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482617570
• Device Catalogue Number: 482617570
• Device Lot Number: C02542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1