MAUDE Adverse Event Report: STRYKER SPINE-US UNSPECIFIED SERRATO DEVICE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 03/14/2024

Event Type  Injury  

Event Description

A company representative reported that a patient has experienced impaired wound healing and the treating surgeon suspects infection.The patient was implanted with an unspecified serrato device.No additional information has been provided and it is unknown if the patient has received additional treatment or if revision surgery is planned.

Manufacturer Narrative

H3 other text : device remains implanted.

• Brand Name: UNSPECIFIED SERRATO DEVICE
• 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: 19101389
• MDR Text Key: 340067025
• Report Number: 0009617544-2024-00039
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/15/2024
• 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 Outcome(s): Other
• Patient Sex: Male