MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS DEPUY EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2011

Event Type  Injury  

Event Description

The patient had a reconstructive spinal surgery involving thoracic 2 (t2) to pelvis on (b)(6) 2009.The surgery consisted in the setting of rods and screws, along with auto-graft and allograft as part of the reconstruction.On (b)(6) 2011, she heard a pop in her back and was seen in the office at the clinic on (b)(6) 2011.At that visit, she had spinal x-rays performed that showed a broken rod at approximately l4-l5.Therefore she had a surgery on (b)(6) 2011 for hardware removal and re - instrumentation at levels thoracic 11 (t11) to pelvis that required hospitalization.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEPUY EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS
• MDR Report Key: 17524886
• MDR Text Key: 321136122
• Report Number: MW5131828
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR