MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482677580
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two xia serrato medial biased polyaxial screws "popped-out" 5 months post-operatively.Revision has been performed.This report will capture the first of two screws.
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.Due to a lack of information and the device not being returned, the root cause of the reported event can not be determined.Potential root causes include: user error (unstable construct); incorrect or small-sized screws implanted; poor bone quality of patient; patient experiences a fall or trauma post-surgery; high activity level of patient post-surgery h3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that two xia serrato medial biased polyaxial screws "popped-out" 5 months post-operatively.Revision has been performed.This report will capture the first of two screws.

• Brand Name: 7.5X70 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: 11396702
• Report Number: 3005525032-2021-00008
• Device Sequence Number: 1219909
• Product Code: NKB
• UDI-Device Identifier: 07613327351699
• UDI-Public: 07613327351699
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 482677580
• Device Catalogue Number: 482677570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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
• Patient Age: 64 YR