MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482802745

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/20/2018

Event Type  Injury  

Event Description

It was reported that the screw head came off post-operatively.Per the correspondence with rep, the patient underwent revision surgery on (b)(6) 2018 to replace hardware of bigger size.This will be reported as a serious injury due to medical intervention.The rod was also replaced in revision surgery, however, no issue was reported for the rod.

Manufacturer Narrative

Method: x-ray image review, visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment results: the reported event of was confirmed via x-ray images and visual inspection of the returned device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Inspection of the returned device confirmed deformation on the tulip head locking ring and on the head of the screw shank.Deformation of tulip head locking ring indicates that the screw shaft was pressing against deformed side of the tulip head likely due to over angulation on screw.Deformation on the screw shank and x-ray images also indicate over-angulation on the screw.Conclusion: the likely root cause of the reported event is the over-angulation of the screw.Other plausible cause could be poor bone quality of the patient.

Event Description

It was reported that the screw head came off post-operatively.Per the correspondence with rep, the patient underwent revision surgery on (b)(6) 2018 to replace hardware of bigger size.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8203241
• MDR Text Key: 131642071
• Report Number: 0009617544-2018-00306
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482802745
• Device Lot Number: 189368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention