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

Model Number	482619580
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Updated b5 with the additional surgical delay information received.

• Brand Name: 9.5X80 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11032257
• Report Number: 3005525032-2020-00047
• Device Sequence Number: 1087695
• Product Code: NKB
• UDI-Device Identifier: 07613327352047
• UDI-Public: 07613327352047
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 482619580
• Device Catalogue Number: 482619580
• Device Lot Number: B73958
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 04/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/16/2021; 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1