MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X80 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482619580

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Event Description

It was reported that while putting the set screw on, the xia serrato polyaxial screw tulip head disengaged intra-operatively.The procedure was completed successfully with an unknown surgical delay.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufauring issues or similar complaints were identified.Initial report stated that the screw head came off screw while putting set screw on.Follow up confirmed that this screw had been implanted for 2-3 years.While tightening a set screw onto the tulip, the tulip head disengaged.Root cause could not be conclusively determined as the device was not returned.Most likely root cause is due to excessive force or overtightening of blocker.Misalignment of blocker before tightening may have also contributed to the event.H3 other text : device not returned.

Event Description

It was reported that while putting the set screw on, the xia serrato polyaxial screw tulip head disengaged intra-operatively.All the fractured pieces were removed from the surgical site and the procedure was completed successfully with a 30 minute delay.No adverse consequences or medical intervention were reported.

Event Description

It was reported that while putting the set screw on, the xia serrato polyaxial screw tulip head disengaged intra-operatively.All the fractured pieces were removed from the surgical site and the procedure was completed successfully with a 30 minute delay.No adverse consequences or medical intervention were reported.

Manufacturer Narrative

Updated b5 with the additional surgical delay information received.

• Brand Name: 9.5X80 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11032257
• MDR Text Key: 222710641
• Report Number: 3005525032-2020-00047
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327352047
• UDI-Public: 07613327352047
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 482619580
• Device Catalogue Number: 482619580
• Device Lot Number: B73958
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/08/2021; 04/28/2021
• Supplement Dates FDA Received: 02/16/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1