MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482617550
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final tightening of a blocker, the xia serrato polyaxial screw tulip disengaged intra-operatively.The procedure was successfully completed without surgical delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during final tightening of a blocker, the xia serrato polyaxial screw tulip disengaged intra-operatively.The procedure was successfully completed without surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Corrected data: g.1.Manufacturing site for devices has been corrected from 'stryker spine france' to 'stryker spine switzerland'.
Additional Manufacturer Narrative
Visual inspection: the threading of the tulip was found to be deformed, indicative of blocker misalignment or cross threading.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per 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.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.Based on the returned implants, the most likely cause is misalignment or cross threading of the blocker.
Event or Problem Description
It was reported that during final tightening of a blocker, the xia serrato polyaxial screw tulip disengaged intra-operatively.The procedure was successfully completed without surgical delay.No adverse consequences or medical intervention were reported.

• Brand Name: 7.5X50 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10805040
• Report Number: 3005525032-2020-00043
• Device Sequence Number: 16945083
• Product Code: NKB
• UDI-Device Identifier: 07613327352641
• UDI-Public: 07613327352641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 482617550
• Device Catalogue Number: 482617550
• Device Lot Number: B91762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 12/30/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 11/09/2020; 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1