MAUDE Adverse Event Report: STRYKER SPINE-US ES2 HEX STRAIGHT ROD 5.5 X 60MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482807060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Numbness (2415)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient will be revised to address one fractured es2 straight rod and two fractured xia titanium rods.The patient has reported numbness and weakness in their lower extremities.This report captures the es2 straight rod.
Additional Manufacturer Narrative
H3 other text : no product returned.

• Brand Name: ES2 HEX STRAIGHT ROD 5.5 X 60MM
• 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: 18540158
• Report Number: 0009617544-2024-00012
• Device Sequence Number: 12661804
• Product Code: NKB
• UDI-Device Identifier: 07613327001495
• UDI-Public: 07613327001495
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

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 Catalogue Number: 482807060
• Device Lot Number: 9CV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 29 YR
• Patient Sex: Male
• Patient Weight: 65 KG