MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problem Fracture (1260)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent revision surgery to address two fractured xia rods and a migrated xia blocker at right s1.The surgeon reported that metallosis was observed at the l5/s1 site and there was no evidence of osteolysis around any of the lower screws.This report captures the second of two fractured xia rods.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.H3 other text: no product returned.

Event Description

It was reported that a patient underwent revision surgery to address two fractured xia rods and a migrated xia blocker at right s1.The surgeon reported that metallosis was observed at the l5/s1 site and there was no evidence of osteolysis around any of the lower screws.This report captures the second of two fractured xia rods.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• 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: 15936195
• MDR Text Key: 305043607
• Report Number: 0009617544-2022-00112
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 70 YR
• Patient Sex: Female