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

Model Number 482678580

Device Problem Misassembled (1398)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that a xia serrato polyaxial screw was not able to be fully final tightened intra-operatively.The surgeon left the screw as is and completed the procedure.No adverse consequences or surgical delays were reported.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained as the device remains implanted in the patient.It was reported that at the time of final tightening, the fastening force weakened before the appropriate torque of 12nm was reached as the serrato surgical technique states.A root cause cannot be determined.Possible causes include cross threading/misalignment of the blocker, rod not fully reduced before final tightening, excessive force applied, overtightening, anti torque not used, and/or torque wrench not fully inserted into blocker.

Event Description

It was reported that a xia serrato polyaxial screw was not able to be fully final tightened intra-operatively.The surgeon left the screw as is and completed the procedure.No adverse consequences or surgical delays were reported.

• Brand Name: 8.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11016218
• MDR Text Key: 222711897
• Report Number: 3005525032-2020-00044
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351873
• UDI-Public: 07613327351873
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482678580
• Device Catalogue Number: 482678580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR