MAUDE Adverse Event Report: STRYKER SPINE STRYKER SPINE ES2 PEDICLE SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 11/26/2019

Event Type  Injury  

Event Description

Pt had stryker es2 pedicle screws placed and tightened to specifics.In room stryker rep confirmed final tightening.At 2 months began to hear noise from the hardware.Locking cap became loose and had to be revised.On operating room inspection, cap nut had backed off and had significant wear debris.Hardware in perfect position but it failed.Pain increase correlated with hearing sounds from pt's back on lateral bending.Fda safety report id# (b)(4).

• Brand Name: STRYKER SPINE ES2 PEDICLE SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE
• MDR Report Key: 9391814
• MDR Text Key: 168466082
• Report Number: MW5091354
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 113