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

Model Number	482678580
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11016218
• Report Number: 3005525032-2020-00044
• Device Sequence Number: 13641465
• Product Code: NKB
• UDI-Device Identifier: 07613327351873
• UDI-Public: 07613327351873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• 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): 04/22/2021

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: 482678580
• Device Catalogue Number: 482678580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR