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

Catalog Number	482616545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains implanted in the patient.
Event or Problem Description
A physician reported that, while implanting a 6.5 mm serrato pedicle screw at l-5 s1, the pedicle broke.The physician was able to complete the procedure using the same serrato pedicle screw at the same level; no extension of the construct was necessary.This event resulted in a 10-minute surgical delay.No adverse consequence to the patient.
Event or Problem Description
A physician reported that, while implanting a 6.5 mm serrato pedicle screw at l-5 s1, the pedicle broke.The physician was able to complete the procedure using the same serrato pedicle screw at the same level; no extension of the construct was necessary.This event resulted in a 10-minute surgical delay.No adverse consequence to the patient.
Additional Manufacturer Narrative
Visual, dimensional, material analysis and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the serrato surgical technique: for increased bone purchase, use the taps to prepare the pedicle canal.After attaching a xia 3 handle, insert the tap into the pedicle and into the vertebral body.With the pedicle pathway prepared, and the proper screw diameter and length determined, insert the screw into the pedicle using the appropriate screwdriver.The serrato polyaxial titanium self-tapping screws have serrations to ease screw insertion.However, in most cases, tapping is recommended.For larger diameter screws, there is more torque applied at the upper part of the screw due to the cancellous cortical thread design combined with a dual lead.Undertapping may cause the screw to become bound in the bone, and with the excess torque applied to drive the screw down, may cause the pedicle to fracture.Possible root causes include lack of tapping, undertapping, difficult angle, and/or excess torque applied.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• 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: 8915179
• Report Number: 3005525032-2019-00072
• Device Sequence Number: 10826377
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482616545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1