MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 55; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48145555
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that the xia polyaxial screw, implanted in the ilio region, pulled out post-operatively.The patient was revised to remove and replace the reported screw with a larger diameter screw.
Event or Problem Description
It was reported that the xia 4.5 polyaxial screw, implanted in the ilio region, pulled out post-operatively.The patient was revised one hour after initial procedure, to remove and replace the reported screw with a larger diameter screw.
Additional Manufacturer Narrative
Updated manufacturing site in g1 to stryker spine-france.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records and complaint history were reviewed for the corresponding lot number, and no relevant issues or similar complaints were identified.The xia surgical technique guide was reviewed for adverse effects in pediatrics and potential root causes: additional adverse effects for pediatric patients: inability to use pedicle screw fixation due to limitations (pedicle dimensions and/or distorted anatomy).Pedicle screw mispositioning, with or without neurological or vascular injury.A root cause could not be establish as the reported device, x-rays, and information regarding the initial procedure were not provided.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.5 X 55
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; -; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12256716
• Report Number: 3005525032-2021-00034
• Device Sequence Number: 19715809
• Product Code: NKB
• UDI-Device Identifier: 07613154122509
• UDI-Public: 07613154122509
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48145555
• Device Catalogue Number: 48145555
• Device Lot Number: 099405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female