MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X70 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482618570
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Doctor has kept the device.
Event or Problem Description
It was reported that the tulip of a xia serrato polyaxial screw located at s5 "came apart" from the shaft post-operatively.Revision surgery has been performed where the screw was explanted.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Photos were provided showing the tulip disengaged from the shank.Photos were not clear enough to make out any deformation or witness marks on the screw.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.As the device was not returned and no further information was provided, a cause cannot be determined.According to the ifu, possible causes include patient activity level, patient fall, patient weight, and/or improper implantation.
Event or Problem Description
It was reported that the tulip of a xia serrato polyaxial screw located at s5 "came apart" from the shaft post-operatively.Revision surgery has been performed where the screw was explanted.

• Brand Name: 8.5X70 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10693098
• Report Number: 3005525032-2020-00041
• Device Sequence Number: 16908716
• Product Code: NKB
• UDI-Device Identifier: 07613327351736
• UDI-Public: 07613327351736
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 12/23/2020

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: 482618570
• Device Catalogue Number: 482618570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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