MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482616545
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
It was reported that a serrato polyaxial screw loosened post operatively.Patient underwent revision surgery.
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.The patient's post-op activity was not stated and no x-rays were provided.Patient's bone quality was not indicated.Since no device was received by stryker, a conclusive cause for the failure mode could not be identified.No further investigation can be performed due to insufficient information provided.H3 other text : remains implanted in patient.
Event or Problem Description
It was reported that a serrato polyaxial screw loosened post operatively.Patient underwent revision surgery.

• Brand Name: 6.5X45 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11150003
• Report Number: 3005525032-2021-00002
• Device Sequence Number: 3488733
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 482616545
• Device Catalogue Number: 482616545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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