MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 5.5 X 35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	488515535
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported that during a pre-scheduled fusion extension surgery, the tulip head of the right and left l5 screw was not attached to the shaft.Patients previous surgery was done prior to (b)(6) of 2016.No adverse consequences to the patient.The surgery was completed successfully.
Event or Problem Description
The surgeon reported that during a pre-scheduled fusion extension surgery, the tulip head of the right and left l5 screw was not attached to the shaft.Patients previous surgery was done prior to december of 2016.No adverse consequences to the patient.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection confirmed a screw returned in 2 pieces and the tulip head disengaged from the screw shank.Additionally, deformation was noted on the bottom of the tulip head; no deformation to the threads.Functional inspection could not be performed because the device was confirmed to be damaged during visual inspection.Dimensional inspection was not performed because there¿s no indication the event was related to dimensions of the device.Material analysis was not performed as this event is unrelated to the material properties of the device.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.The likely root cause of the event is instability of the construct.Furthermore, the device was implanted for approximately 3 years; length of the implantation may have contributed to the event.In addition, contributing factors: surgeon "white knuckles" the torque wrench.Surgeon unable to read the laser marking.Atk is not fully connected to the screw.Torque wrench is not able to provide enough torque.Per the surgical technique: ¿line up the two arrows to achieve the final tightening torque of 8nm.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Note: do not exceed 8nm during final tightening.The anti-torque key must be used for final tightening." from the xia ifu: "while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.".

• Brand Name: POLYAXIAL CORTICAL SCREW 5.5 X 35
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8573165
• Report Number: 0009617544-2019-00064
• Device Sequence Number: 16771964
• Product Code: NKB
• UDI-Device Identifier: 07613327137347
• UDI-Public: 07613327137347
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• 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
• Report Date (Section B): 07/09/2019

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 Catalogue Number: 488515535
• Device Lot Number: 165239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1