MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482317545
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tulip of the xia defense screw broke off intra-op when surgeon was in process of final tightening.A surgical delay of 10 min was reported.No other consequence to the patient was reported.
Additional Manufacturer Narrative
Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.Complaint history review for similar events and device history records could not be performed as a valid lot code was not provided and could not be obtained.It was reported that a screw tulip disengagement intra-operatively.Root cause could not be determined conclusively.However, when the tulip disengages from screw one common reason is due to the tulip being over angled while persuading.Cantilever forces would cause this.
Event or Problem Description
It was reported that tulip of the xia defense screw broke off intra-op when surgeon was in process of final tightening.A surgical delay of 10 min was reported.No other consequence to the patient was reported.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8387706
• Report Number: 3005525032-2019-00005
• Device Sequence Number: 18887824
• Product Code: NKB
• UDI-Device Identifier: 04546540562357
• UDI-Public: 04546540562357
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: No Information
• Device Catalogue Number: 482317545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR