MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X45 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482616545

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient experienced a post-operative serrato polyaxial screw fracture.Revision surgery has not been performed.

Manufacturer Narrative

H3 other text : device remains implanted.

Manufacturer Narrative

H6 coding has been updated to reflect investigation conclusion.

Event Description

It was reported that a patient experienced a post-operative serrato polyaxial screw fracture.Revision surgery has not been performed.

• Brand Name: 6.5X45 POLYAXIAL SCREW
• 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: 17969788
• MDR Text Key: 326375994
• Report Number: 0009617544-2023-00064
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327352658
• UDI-Public: 07613327352658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482616545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 53 YR
• Patient Sex: Male