MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL CORTICAL SCREW 4.5 X 35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	488514535
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient heard a clicking noise every time they twisted or stood up 30 days post-op.Physician reported that a xia ct polyaxial cortical screw 4.5 x 35 migrated post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Visual inspection: a screw, two rods and four blocker were returned for evaluation.The rods are concomitant products.Slight deformation was observed on the screw threads.No other visual anomalies were identified.Post-op x-rays were provided showing that a top blocker migrated out of the screw.The remaining 3 blockers are dislodged.Functional inspection: all blockers were able to hold down a test rod in the screw.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.From the xia 4.5 surgical technique: 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.To final tighten; use the anti-torque key and the torque wrench: step 1: place the anti-torque key over the screw head.Step 2: place the torque wrench through the anti-torque key until it is guided into the blocker.Step 3: 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.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.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.The most likely root cause of the construct loosening is inconsistency in tightening the blockers.
Event or Problem Description
Patient heard a clicking noise every time they twisted or stood up 30 days post-op.Physician reported that a xia ct polyaxial cortical screw 4.5 x 35 migrated post-operatively.Revision surgery was performed.

• Brand Name: POLYAXIAL CORTICAL SCREW 4.5 X 35
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9418945
• Report Number: 0009617544-2019-00131
• Device Sequence Number: 16789190
• Product Code: NKB
• UDI-Device Identifier: 07613327134278
• UDI-Public: 07613327134278
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 488514535
• Device Catalogue Number: 488514535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR