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

Model Number	482618580
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tulips of 3 xia serrato polyaxial screws popped off the shanks intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an unspecified surgical delay by using alternatively available implants.This report captures the first of the three screws.
Additional Manufacturer Narrative
Visual: visual inspection confirmed that the tulip head disengaged from screw shank.There is deformation on the locking ring of tulip head.Screw shank bulb has two deep deformation on either side of shank bulb.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Screw shank bulb also has multiple deep deformations in two separate locations.Shank bulb deformation shows evidence that rod was attempted to be tightened multiple times.Deformation on tulip ring and shank bulb head both indicate that excessive force was applied to tulip head during provisional and/or final tightening, while tulip head was over angulated.Sgt was reviewed: once the correction procedures have been carried out and the spine is fixed in a satisfactory position, the final tightening of the blockers is performed.Use the anti-torque key and the torque wrench.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.Note: do not exceed 12nm during final tightening.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.Correct handling of the implant is extremely important.The operating surgeon should avoid notching or scratching the device.The most likely cause of the reported event was determined to be excessive force/torque applied during provisional or final tightening while tulip head was over angulated.Use of universal tightener to final tighten and/or not using torque wrench during final tightening may have also contributed to reported event.Multiple attempts to final tighten may have also contributed to reported event, as each attempt deforms the shank bulb head.
Event or Problem Description
It was reported that the tulips of 3 xia serrato polyaxial screws popped off the shanks intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with an unspecified surgical delay by using alternatively available implants.This report captures the first of the three screws.

• Brand Name: 8.5X80 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11807125
• Report Number: 3005525032-2021-00018
• Device Sequence Number: 11692884
• Product Code: NKB
• UDI-Device Identifier: 07613327351187
• UDI-Public: 07613327351187
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/25/2021

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: 482618580
• Device Catalogue Number: 482618580
• Device Lot Number: B93149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR