MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482677580
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final tightening a xia serrato polyaxial screw tulip disengaged from the screw shaft intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection confirmed that the tulip is disengaged from the screw shank.There is deformation in multiple locations on tulip locking ring.Screw shank bulb has deformation from rod biased to the outer edge of bulb head.There is also deformation on the locking teeth of screw adjacent to the deformation on bulb head.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that rod was fully reduced and that the torque wrench and counter torque key were used for final tightening to 12nm.Based on the damage seen on the locking ring and the screw shank bulb, the most likely root cause is over angulation applied to the screw/tulip interface causing the tulip to disengage during final tightening.
Event or Problem Description
It was reported that during final tightening a xia serrato polyaxial screw tulip disengaged from the screw shaft intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.

• Brand Name: 7.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11602977
• Report Number: 3005525032-2021-00012
• Device Sequence Number: 11799901
• Product Code: NKB
• UDI-Device Identifier: 07613327351699
• UDI-Public: 07613327351699
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: No Information
• Device Model Number: 482677580
• Device Catalogue Number: 482677580
• Device Lot Number: B84295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 130