MAUDE Adverse Event Report: STRYKER SPINE-US XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 6.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482366545

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 06/14/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent revision surgery to address a xia uniplanar reduction screw fracture approximately 2.5 weeks after implantation.Patient reported low back pain.

Event Description

It was reported that a patient underwent revision surgery to address a xia uniplanar reduction screw fracture approximately 2.5 weeks after implantation.Patient reported low back pain.The returned product revealed screw tulip disengagement and not fracture.

Manufacturer Narrative

Additional data: b5, d9, h3, h4.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 6.5 X 45MM
• Type of Device: 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: 17317630
• MDR Text Key: 319010479
• Report Number: 0009617544-2023-00054
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 482366545
• Device Lot Number: 224603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 95 KG