MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL (DEPUY SPINE, INC.) EXPEDIUM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number 179702535

Device Problem Insufficient Information (3190)

Patient Problem Paraplegia (2448)

Event Date 06/06/2017

Event Type  Injury  

Event Description

A young girl with severe adolescent idiopathic scoliosis presented for elective posterior spinal fusion and bone grafting of t4-l4 vertebrae, as well as epidural catheter placement at t6 and t12.The patient was transported to the or at 0739.Motor potentials were unable to be obtained from the start of the surgery.Two dimensional c-arm x-rays were completed intra-op.No concerns were noted.The surgery was completed at 1457 without any challenges.A "wake up" test was performed per recommended guidelines to assess sensorimotor functioning in the absence of intra-op monitoring.Upon awaking, the patient was unable to move her feet.She was extubated and brought to the post anesthesia unit for full wake-up.She had sensation of her legs but was unable to move them.She had an emergent ct scan that showed 3 pedicle screws in the spinal canal.She was brought back to the or to have the screws removed.She continued to have incomplete paraplegia after surgery, including a loss of bowel and bladder control.She was treated with decadron and ketorolac.She regained some movement in her left lower extremity and was reporting bladder fullness and the sensation to void.Last report is that the patient is at home walking with crutches, using a wheelchair when fatigued.Range of motion on her right lower extremity is nearly normal but still lacks strength.Her bladder control is improving, with less retention when voiding, but straight catheterizations are still required.

• Brand Name: EXPEDIUM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL (DEPUY SPINE, INC.); karen mahoney; 325 paramount dr; raynham MA 02767
• MDR Report Key: 7103784
• MDR Text Key: 94394160
• Report Number: 7103784
• Device Sequence Number: 0
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 179702535
• Device Catalogue Number: 179702535
• Other Device ID Number: MONOAXIAL SCREW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LIFENET HEALTH. ID: (B)(6) CODE: CC1/4 EX
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 12 YR